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U.S. Department of Health and Human Services

Class 2 Device Recall MiSeq Dx Instrument

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 Class 2 Device Recall MiSeq Dx Instrumentsee related information
Date Initiated by FirmMay 03, 2022
Create DateJune 13, 2022
Recall Status1 Completed
Recall NumberZ-1259-2022
Recall Event ID 90160
Product Classification High throughput DNA sequence analyzer - Product Code PFF
Productillumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Code Information Model Numbers: DX-410-1001; 15036706; 20014053; UDI-DI Code: 00816270020002 00816270020699 All Instruments containing Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: M71006-20014737 M70955-20014737 M70992-20014737 M70999-20014737 M70957-20014737 M70989-20014737 M70983-20014737 M70979-20014737 M70971-20014737 M70977-20014737 M70968-20014737 M70938-20014737 M70951-20014737 M70770-20014737 M70956-20014737 M70958-20014737 M70946-20014737 M70939-20014737 M70922-20014737 M70905-20014737 M70932-20014737 M70904-20014737 M70925-20014737 M70894-20014737 M70906-20014737 M70892-20014737 M70899-20014737 M70897-20014737 M70865-20014737 M70882-20014737 M70879-20014737 M70883-20014737 M70868-20014737 M70880-20014737 M70878-20014737 M70864-20014737 M70858-20014737 M70861-20014737 M70797-20014737 M70842-20014737 M70843-20014737 M70855-20014737 M70848-20014737 M70840-20014737 M70826-20014737 M70818-20014737 M70822-20014737 M70827-20014737 M70815-20014737 M70296-15037414 M70813-20014737 M70814-20014737 M70810-20014737 M70799-20014737 M70809-20014737 M70803-20014737 M70804-20014737 M70805-20014737 M70806-20014737 M70808-20014737 M70807-20014737 M70767-20014737 M70795-20014737 M70789-20014737 M70790-20014737 M70792-20014737 M70793-20014737 M70784-20014737 M70791-20014737 M70794-20014737 M70742-20014737 M70723-20014737 M70781-20014737 M70776-20014737 M70778-20014737 M70779-20014737 M70773-20014737 M70739-20014737 M70774-20014737 M70744-20014737 M70771-20014737 M70777-20014737 M70750-20014737 M70753-20014737 M70769-20014737 M70761-20014737 M70765-20014737 M70554-20014737 M70745-20014737 M70746-20014737 M70747-20014737 M70748-20014737 M70749-20014737 M70551-20014737 M70754-20014737 M70755-20014737 M70743-20014737 M70741-20014737 M70721-20014737 M70733-20014737 M70731-20014737 M70728-20014737 M70732-20014737 M70729-20014737 M70730-20014737 M70725-20014737 M70724-20014737 M70726-20014737 M70715-20014737 M70713-20014737 M70707-20014737 M70710-20014737 M70714-20014737 M70708-20014737 M70709-20014737 M70705-20014737 M70562-20014737 M70706-20014737 M70703-20014737 M70701-20014737 M70571-20014737 M70574-20014737 M70573-20014737 M70492-15037414 M70568-20014737 M70560-20014737 M70559-20014737 M70569-20014737 M70538-15037414 M70567-20014737 M70558-20014737 M70531-20014737 M70556-20014737 M70535-20014737 M70566-20014737 M70565-20014737 M70524-20014737 M70537-20014737 M70526-20014737 M70530-20014737 M70532-20014737 M70523-20014737 M70520-15037414 M70521-15037414 M70517-15037414 M70519-15037414 M70516-15037414 M70518-15037414 M70515-15037414 M70451-15037414 M70453-15037414 M70454-15037414 M70456-15037414 M70514-15037414 M70461-15037414 M70462-15037414 M70489-15037414 M70491-15037414 M70499-15037414 M70506-15037414 M70467-15037414 M70468-15037414 M70460-15037414 M70463-15037414 M70464-15037414 M70270-15037414 M70457-15037414 M70458-15037414 M70408-15037414 M70409-15037414 M70445-15037414 M70447-15037414 M70448-15037414 M70446-15037414 M70466-15037414 M70433-15037414 M70487-15037414 M70438-15037414 M70504-15037414 M70442-15037414 M70430-15037414 M70432-15037414 M70441-15037414 M70435-15037414 M70429-15037414 M70427-15037414 M70400-15037414 M70424-15037414 M70348-15037414 M70362-15037414 M70354-15037414 M70327-15037414 M70399-15037414 M70361-15037414 M70332-15037414 M70360-15037414 M70329-15037414 M70404-15037414 M70358-15037414 M70412-15037414 M70426-15037414 M70421-15037414 M70415-15037414 M70422-15037414 M70269-15037414 M70374-15037414 M70291-15037414 M70401-15037414 M70389-15037414 M70391-15037414 M70402-15037414 M70383-15037414 M70403-15037414 M70384-15037414 M70385-15037414 M70381-15037414 M70379-15037414 M70386-15037414 M70393-15037414 M70392-15037414 M70378-15037414 M70375-15037414 M70337-15037414 M70356-15037414 M70323-15037414 M70366-15037414 M70330-15037414 M70363-15037414 M70364-15037414 M70359-15037414 M70284-15037414 M70295-15037414 M70341-15037414 M70314-15037414 M70343-15037414 M70305-15037414 M70333-15037414 M70338-15037414 M70319-15037414 M70340-15037414 M70334-15037414 M70336-15037414 M70324-15037414 M70331-15037414 M70339-15037414 M70325-15037414 M70278-15037414 M70322-15037414 M70306-15037414 M70313-15037414 M70320-15037414 M70321-15037414 M70290-15037414 M70247-15037414 M70300-15037414 M70312-15037414 M70307-15037414 M70274-15037414 M70254-15037414 M70304-15037414 M70301-15037414 M70303-15037414 M70288-15037414 M70256-15037414 M70267-15037414 M70276-15037414 M70277-15037414 M70287-15037414 M70238-15037414 M70251-15037414 M70258-15037414 M70264-15037414 M70236-15037414 M70268-15037414 M70260-15037414 M70257-15037414 M70239-15037414 M70245-15037414 M70255-15037414 M70241-15037414 M70234-15037414 M70233-15037414 M70204-15037414 M70240-15037414 M70203-15037414 M70170-15037414 M70209-15037414 M70232-15037414 M70224-15037414 15037414M70228 M70231-15037414 M70201-15037414 M70206-15037414 M70225-15037414 M70229-15037414 M70212-15037414 M70216-15037414 M70210-15037414 M70174-15037414 M70207-15037414 M70186-15037414 M70205-15037414 M70208-15037414 M70168-15037414 M70173-15037414 M70198-15037414 M70211-15037414 M70189-15037414 M70176-15037414 M70175-15037414 M70177-15037414 M70162-15037414 M70166-15037414 M70169-15037414 M70172-15037414 M70165-15037414 M70159-15037414 M70156-15037414 M70158-15037414 M70160-15037414 15037414M70155 15037414M70157 M70153-15037414 M70144-15037414 15037414M70148 15037414M70149 15037414M70150 15037414M70151 15037414M70152 15037414M70142 15037414M70145 15037414M70147 M70137-15037414 M70139-15037414 M70131-15037414 M70143-15037414 M70107-15037414 M70108-15037414 M70114-15037414 M70136-15037414 M70116-15037414 M70135-15037414 M70130-15037414 M70132-15037414 M71002-20014737 M70995-20014737 M71001-20014737 M70289-15037414 O.US.: M71012-20014737 M71013-20014737 C70341-20014054 M71010-20014737 M71005-20014737 M71009-20014737 C70386-20014054 C70408-20014054 M71007-20014737 C70376-20014054 M70980-20014737 C70349-20014054 M70981-20014737 M71008-20014737 M71004-20014737 M71003-20014737 M70982-20014737 C70395-20014054 C70409-20014054 M70996-20014737 M70991-20014737 M71000-20014737 M70990-20014737 C70361-20014054 M70975-20014737 M70997-20014737 M70994-20014737 C70403-20014054 C70407-20014054 C70398-20014054 M70993-20014737 C70404-20014054 M70998-20014737 C70384-20014054 M70970-20014737 M70965-20014737 M70969-20014737 C70204-20014054 C70401-20014054 C70402-20014054 C70400-20014054 M70984-20014737 C70365-20014054 M70963-20014737 M70976-20014737 M70959-20014737 M70988-20014737 C70324-20014054 C70375-20014054 C70385-20014054 C70138-20014054 C70155-20014054 C70334-20014054 M70974-20014737 M70962-20014737 M70985-20014737 M70972-20014737 M70950-20014737 C70387-20014054 M70966-20014737 C70355-20014054 C70389-20014054 M70961-20014737 C70357-20014054 M70775-20014737 M70960-20014737 M70967-20014737 C70391-20014054 M70921-20014737 M70918-20014737 M70941-20014737 C70350-20014054 M70953-20014737 M70875-20014737 M70920-20014737 M70928-20014737 C70374-20014054 C70381-20014054 C70390-20014054 M70914-20014737 M70829-20014737 M70948-20014737 M70912-20014737 M70944-20014737 M70885-20014737 M70952-20014737 M70917-20014737 M70915-20014737 M70949-20014737 M70943-20014737 C70312-20014054 C70378-20014054 C70367-20014054 C70346-20014054 M70786-20014737 M70945-20014737 C70380-20014054 M70942-20014737 C70369-20014054 C70370-20014054 C70372-20014054 M70787-20014737 C70368-20014054 C70303-20014054 C70366-20014054 C70287-20014054 C70359-20014054 C70363-20014054 M70940-20014737 C70290-20014054 M70898-20014737 M70934-20014737 M70933-20014737 C70364-20014054 M70931-20014737 M70873-20014737 M70929-20014737 M70927-20014737 C70311-20014054 M70924-20014737 M70870-20014737 C70338-20014054 C70354-20014054 C70347-20014054 M70937-20014737 M70926-20014737 M70911-20014737 M70923-20014737 M70907-20014737 C70316-20014054 M70935-20014737 M70900-20014737 M70455-15037414 C70321-20014054 M70916-20014737 C70323-20014054 C70351-20014054 M70930-20014737 M70895-20014737 M70908-20014737 M70893-20014737 M70910-20014737 M70936-20014737 C70315-20014054 C70260-20014054 C70356-20014054 C70343-20014054 C70171-20014054 C70358-20014054 M70902-20014737 C70322-20014054 M70913-20014737 M70909-20014737 C70344-20014054 C70330-20014054 C70340-20014054 C70348-20014054 M70901-20014737 C70165-20014054 M70903-20014737 C70325-20014054 C70345-20014054 M70888-20014737 C70329-20014054 C70319-20014054 M70854-20014737 C70362-20014054 M70884-20014737 M70896-20014737 C70293-20014054 C70328-20014054 C70336-20014054 M70876-20014737 M70889-20014737 M70837-20014737 M70845-20014737 C70249-20014054 M70887-20014737 C70244-20014054 C70292-20014054 C70342-20014054 M70866-20014737 C70314-20014054 M70853-20014737 M70857-20014737 C70332-20014054 C70327-20014054 M70890-20014737 M70867-20014737 M70869-20014737 M70891-20014737 C70302-20014054 C70291-20014054 M70886-20014737 M70820-20014737 C70317-20014054 C70243-20014054 C70307-20014054 M70860-20014737 C70294-20014054 C70335-20014054 C70203-20014054 C70261-20014054 C70256-20014054 M70862-20014737 C70240-20014054 C70320-20014054 M70846-20014737 C70306-20014054 C70299-20014054 M70841-20014737 M70847-20014737 M70852-20014737 M70856-20014737 M70859-20014737 C70301-20014054 M70877-20014737 M70863-20014737 M70871-20014737 M70872-20014737 M70874-20014737 M70851-20014737 C70270-20014054 C70251-20014054 C70313-20014054 M70849-20014737 C70300-20014054 C70310-20014054 C70289-20014054 C70279-20014054 M70850-20014737 C70284-20014054 C70305-20014054 C70298-20014054 C70297-20014054 C70295-20014054 C70258-20014054 C70272-20014054 C70273-20014054 C70263-20014054 M70833-20014737 C70206-20014054 C70288-20014054 M70834-20014737 M70838-20014737 C70285-20014054 C70232-20014054 C70275-20014054 M70831-20014737 C70262-20014054 C70247-20014054 C70236-20014054 C70255-20014054 M70819-20014737 C70271-20014054 C70286-20014054 C70274-20014054 M70821-20014737 C70178-20014054 M70762-20014737 C70281-20014054 M70844-20014737 C70239-20014054 C70278-20014054 C70185-20014054 C70282-20014054 C70277-20014054 M70830-20014737 M70832-20014737 C70176-20014054 C70276-20014054 C70257-20014054 C70265-20014054 C70267-20014054 M70825-20014737 C70183-20014054 C70280-20014054 C70283-20014054 M70823-20014737 M70782-20014737 M70824-20014737 C70235-20014054 M70816-20014737 M70828-20014737 C70220-20014054 M70817-20014737 C70254-20014054 C70237-20014054 C70266-20014054 C70205-20014054 C70246-20014054 C70259-20014054 M70756-20014737 C70218-20014054 C70245-20014054 C70242-20014054 C70225-20014054 C70210-20014054 M70812-20014737 C70223-20014054 C70226-20014054 C70238-20014054 C70224-20014054 C70233-20014054 C70160-20014054 C70208-20014054 C70222-20014054 C70230-20014054 C70228-20014054 C70182-20014054 C70186-20014054 C70187-20014054 C70221-20014054 C70231-20014054 C70193-20014054 C70214-20014054 C70209-20014054 M70800-20014737 M70788-20014737 C70216-20014054 C70195-20014054 C70217-20014054 M70798-20014737 C70173-20014054 M70760-20014737 C70202-20014054 M70785-20014737 M70796-20014737 M70801-20014737 M70802-20014737 C70179-20014054 C70201-20014054 C70189-20014054 M70317-15037414 C70177-20014054 C70200-20014054 M70780-20014737 C70207-20014054 C70197-20014054 C70198-20014054 C70164-20014054 M70783-20014737 M70549-20014737 M70881-20014737 M70766-20014737 M70772-20014737 M70763-20014737 C70144-20014054 C70192-20014054 C70180-20014054 M70757-20014737 C70196-20014054 C70174-20014054 C70184-20014054 C70188-20014054 C70168-20014054 C70194-20014054 C70149-20014054 M70751-20014737 C70190-20014054 C70150-20014054 C70172-20014054 C70175-20014054 C70153-20014054 C70161-20014054 C70156-20014054 M70345-15037414 M70163-15037414 M70164-15037414 C70127-20014054 C70147-20014054 C70158-20014054 M70539-20014737 C70167-20014054 C70170-20014054 C70159-20014054 C70162-20014054 C70148-20014054 C70166-20014054 C70163-20014054 M70736-20014737 M70759-20014737 C70142-20014054 C70169-20014054 M70734-20014737 C70140-20014054 M70737-20014737 M70752-20014737 C70152-20014054 C70146-20014054 M70740-20014737 M70536-20014737 M70711-20014737 M70722-20014737 M70540-20014737 C70157-20014054 M70552-15037414 M70553-15037414 C70130-20014054 C70145-20014054 C70141-20014054 C70143-20014054 M70727-20014737 M70735-20014737 C70151-20014054 M70570-20014737 M70486-15037414 M70564-20014737 M70533-20014737 M70717-20014737 C70132-20014054 C70137-20014054 M70718-20014737 C70126-20014054 M70712-20014737 C70136-20014054 C70139-20014054 M70716-20014737 M70544-15037414 M70719-20014737 M70543-15037414 C70131-20014054 C70134-20014054 C70135-20014054 M70563-20014737 C70128-20014054 C70129-20014054 M70547-15037414 M70512-15037414 M70511-15037414 M70417-15037414 C70118-20014054 M70572-20014737 C70124-20014054 M70546-15037414 C70120-20014054 C70125-20014054 M70545-15037414 C70122-20014054 C70123-20014054 C70121-20014054 M70557-15037414 M70522-20014737 M70550-15037414 M70561-15037414 M70510-15037414 M70279-15037414 C70117-20014054 C70114-20014054 M70542-15037414 C70119-20014054 M70488-15037414 M70541-15037414 M70347-15037414 M70509-15037414 M70483-15037414 C70116-20014054 C70115-20014054 M70529-15037414 M70548-15037414 M70534-15037414 M70525-15037414 M70508-15037414 C70113-20014054 M70502-15037414 M70316-15037414 M70528-15037414 M70436-15037414 M70425-15037414 M70428-15037414 M70434-15037414 M70431-15037414 M70423-15037414 M70484-15037414 M70280-15037414 M70437-15037414 M70501-15037414 M70498-15037414 M70474-15037414 20014054C70107 M70497-15037414 M70503-15037414 20014054C70105 M70500-15037414 M70369-15037414 M70493-15037414 M70496-15037414 M70419-15037414 M70444-15037414 M70440-15037414 20014054C70106 20014054C70108 C70112-20014054 20014054C70102 C70111-20014054 20014054C70109 C70110-20014054 M70418-15037414 M70476-15037414 C70104-20014054 C70103-20014054 C70101-20014054 M70420-15037414 M70405-15037414 M70470-15037414 M70477-15037414 M70472-15037414 M70485-15037414 M70413-15037414 M70410-15037414 M70452-15037414 M70390-15037414 M70335-15037414 M70406-15037414 M70388-15037414 M70387-15037414 M70397-15037414 M70373-15037414 M70416-15037414 M70407-15037414 M70398-15037414 M70377-15037414 M70352-15037414 M70382-15037414 M70368-15037414 M70351-15037414 M70349-15037414 M70283-15037414 M70298-15037414 M70310-15037414 M70326-15037414 M70308-15037414 M70311-15037414 M70263-15037414 M70252-15037414 M70227-15037414 M70294-15037414 M70286-15037414 M70281-15037414 M70282-15037414 M70292-15037414 M70293-15037414 M70265-15037414 M70250-15037414 M70191-15037414 M70235-15037414 M70272-15037414 M70273-15037414 M70266-15037414 M70242-15037414 M70243-15037414 M70253-15037414 M70230-15037414 M70226-15037414 M70213-15037414 M70184-15037414 M70223-15037414 M70202-15037414 M70200-15037414 M70192-15037414 M70190-15037414 M70194-15037414 M70185-15037414 M70188-15037414 M70183-15037414 M70182-15037414 M70187-15037414 M70181-15037414 M70109-15037414 M70465-15037414 M70120-15037414 M70115-15037414 M70119-20014737 15037414M70119 M70134-15037414 M70138-15037414 M70141-15037414 M70146-15037414 M70113-15037414 M70103-15037414 M70123-15037414 M70102-15037414 M70104-15037414 M70105-15037414 C70199-20014054 C70191-20014054 C70133-20014054 C70154-20014054 C70181-20014054 C70211-20014054 C70212-20014054 C70213-20014054 C70215-20014054 C70219-20014054 C70252-20014054 C70241-20014054 C70253-20014054 C70264-20014054 C70268-20014054 C70269-20014054 C70304-20014054 C70229-20014054 C70227-20014054 C70234-20014054 C70248-20014054 C70250-20014054 C70326-20014054 C70331-20014054 C70333-20014054 C70339-20014054 C70337-20014054 C70353-20014054 C70296-20014054 C70309-20014054 C70318-20014054 C70308-20014054 C70360-20014054 C70352-20014054 C70371-20014054 C70377-20014054 C70373-20014054 C70392-20014054 C70397-20014054 C70383-20014054 C70382-20014054 C70393-20014054 C70394-20014054 C70379-20014054 C70396-20014054 C70399-20014054 C70405-20014054 C70412-20014054 C70414-20014054 C70410-20014054 C70388-20014054 C70413-20014054 C70411-20014054 C70406-20014054 C70416-20014054 C70415-20014054 C70417-20014054 C70418-20014054 C70419-20014054 C70422-20014054 M70811-20014737 M70839-20014737 M70947-20014737 M70973-20014737 M70987-20014737 M70986-20014737 M71011-20014737 M71017-20014737 M71016-20014737 15037414M70110
FEI Number 3003218906
Recalling Firm/
Manufacturer		 Illumina, Inc.
5200 Illumina Way
San Diego CA 92122-4616
For Additional Information ContactAdi Raval
202-629-8172
Manufacturer Reason
for Recall		cybersecurity vulnerability
FDA Determined
Cause 2		Software in the Use Environment
ActionOn 05/03/2022, Illumina sent via email an "Urgent Medical Device Recall" Letter to customer informing them the cybersecurity vulnerability impacting the NextSeq 550 Dx and MiSeq Dx instruments with software versions 1.3 to 3.1 of the Local Run Manager (LRM) software installed. Customers are also being informed that Illumina has developed a software patch to protect against the exploitation of the vulnerability. Installation of the software patch will block remote access to the LRM web User Interface (web UI). For NextSeq 550Dx and MiSeq Dx instruments connected to the internet, the software patch is available for immediate download through a secure portal. Illumina is currently providing the website address to impacted customers and regulatory authorities only. Illumina recommends that customers download and install the software patch on their instrument(s) promptly. For affected NextSeq 550Dx and MiSeq Dx instruments not connected to the internet, Illumina has developed other options for the installation of the software patch. Impacted customers should contact Tech Support promptly to obtain information about these options. NextSeq 550Dx and MiSeq Dx instruments that have dual boot mode, the customers must install the software patch separately in each mode (Dx mode and RUO mode) of each instrument. It is also important for the customer to install the software patch on any stand-alone instances of the off-instrument LRM for RUO mode on the Dx instruments. Illumina will ask the customer to complete the Urgent Medical Device Recall verification form to confirm receipt of this notification and verify the patch was installed. We will ask the customer to return the form to Technical Support. For questions, email - techsupport@illumina.com
Quantity in Commerce1,014 instruments
DistributionWorldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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