| | Class 2 Device Recall NextSeq 550 Dx Instrument |  |
| Date Initiated by Firm | May 03, 2022 |
|---|
| Create Date | June 13, 2022 |
|---|
| Recall Status1 |
Completed |
| Recall Number | Z-1260-2022 |
|---|
| Recall Event ID |
90160 |
| Product Classification |
High throughput DNA sequence analyzer - Product Code PFF
|
| Product | illumina Model NextSeq 550 Dx REF 20005715 |
|---|
| Code Information |
Model Numbers:
20005715
UDI-DI Code:
00816270020125
All Instruments containing Local Run Manager (LRM) Software version: v.1.3.1 to 3.0
Installed Product ID:
U.S.:
NDX550779-15073937
NDX550504-15073937
NDX550732-15073937
NDX550287-15073937
NDX550802-15073937
NDX550691-15073937
NDX550656-15073937
NDX550725-15073937
NDX550736-15073937
NDX550754-15073937
NDX550151-15073937
NDX550996-15073937
NDX550916-15073937
NDX550420-15073937
NDX550715-15073937
NDX550726-15073937
NDX550729-15073937
NDX550730-15073937
NDX550712-15073937
NDX550722-15073937
NDX550660-15073937
NDX550603-15073937
NDX550601-15073937
NDX550595-15073937
NDX550553-15073937
NDX550568-15073937
NDX550579-15073937
NDX550586-15073937
NDX550590-15073937
NDX550561-15073937
NDX550522-15073937
NDX550535-15073937
NDX550563-15073937
NDX550485-15073937
NDX550547-15073937
NDX550552-15073937
NDX550560-15073937
NDX550537-15073937
NDX550531-15073937
NDX550532-15073937
NDX550533-15073937
NDX550501-15073937
NDX550503-15073937
NDX550474-15073937
NDX550445-15073937
NDX550432-15073937
NDX550378-15073937
NDX550369-15073937
NDX550374-15073937
NDX550115-15073937
NDX550370-15073937
NDX550376-15073937
NDX550381-15073937
NDX550361-15073937
NDX550257-15073937
NDX550313-15073937
NDX550288-15073937
15073937NDX550261
NDX550207-15073937
NDX550149-15073937
NDX550138-15073937
NDX550123-15073937
NDX550105-15073937
NDX550136-15073937
NDX550140-15073937
NDX550914-15073937
NDX550968-15073937
NDX550851-15073937
NDX550962-15073937
NDX550763-15073937
NDX550572-15073937
NDX550276-15073937
NDX550389-15073937
NDX550399-15073937
NDX550409-15073937
NDX550414-15073937
NDX550425-15073937
NDX550427-15073937
NDX550348-15073937
NDX550353-15073937
NDX550337-15073937
NDX550338-15073937
NDX550804-15073937
NDX550365-15073937
NDX550839-15073937
NDX550621-15073937
NDX550490-15073937
NDX550580-15073937
NDX550611-15073937
NDX550608-15073937
NDX550594-15073937
NDX550430-15073937
NDX550385-15073937
NDX550310-15073937
NDX550241-15073937
NDX550201-15073937
NDX550169-15073937
NDX550127-15073937
NDX550915-15073937
NDX550899-15073937
NDX550665-15073937
NDX550468-15073937
NDX550321-15073937
NDX550629-15073937
NDX550803-15073937
NDX550852-15073937
NDX550739-15073937
NDX550662-15073937
NDX550609-15073937
NDX550593-15073937
NDX550228-15073937
NDX550174-15073937
NDX550272-15073937
NDX550246-15073937
NDX550248-15073937
NDX550761-15073937
NDX550658-15073937
NDX550540-15073937
NDX550706-15073937
NDX550816-15073937
NDX550363-15073937
NDX550199-15073937
NDX550200-15073937
NDX550193-15073937
NDX550196-15073937
NDX550180-15073937
NDX550182-15073937
NDX550134-15073937
NDX550139-15073937
NDX550760-15073937
NDX550762-15073937
NDX550543-15073937
NDX550341-15073937
NDX550289-15073937
NDX550224-15073937
NDX550209-15073937
NDX550179-15073937
NDX550125-15073937
NDX550973-15073937
NDX550838-15073937
NDX550477-15073937
NDX550260-15073937
NDX550525-15073937
NDX550380-15073937
NDX550211-15073937
NDX550837-15073937
NDX550811-15073937
NDX550657-15073937
NDX550357-15073937
NDX550364-15073937
NDX550349-15073937
NDX550351-15073937
NDX550218-15073937
NDX550738-15073937
NDX550900-15073937
NDX550965-15073937
NDX550457-15073937
NDX550646-15073937
NDX550343-15073937
NDX550316-15073937
NDX550295-15073937
15073937NDX550244
NDX550167-15073937
NDX550210-15073937
NDX550437-15073937
NDX550459-15073937
NDX550489-15073937
NDX550452-15073937
NDX550442-15073937
NDX550443-15073937
NDX550299-15073937
NDX550311-15073937
NDX550308-15073937
NDX550306-15073937
NDX550307-15073937
NDX550314-15073937
NDX550283-15073937
NDX550177-15073937
NDX550853-15073937
NDX550921-15073937
NDX550597-15073937
NDX550339-15073937
NDX550704-15073937
NDX550606-15073937
NDX550526-15073937
NDX550284-15073937
NDX550305-15073937
NDX550237-15073937
NDX550254-15073937
NDX550215-15073937
NDX550110-15073937
NDX550600-15073937
NDX550545-15073937
NDX550807-15073937
NDX550413-15073937
NDX550992-15073937
NDX550820-15073937
NDX550836-15073937
NDX550827-15073937
NDX550342-15073937
NDX550799-15073937
NDX550589-15073937
NDX550234-15073937
NDX550235-15073937
NDX550238-15073937
NDX550239-15073937
NDX550240-15073937
NDX550104-15073937
NDX550894-15073937
NDX550798-15073937
NDX550620-15073937
NDX550614-15073937
NDX550523-15073937
NDX550506-15073937
NDX550461-15073937
NDX550410-15073937
NDX550483-15073937
NDX550354-15073937
NDX550202-15073937
NDX550826-15073937
NDX550486-15073937
NDX550304-15073937
NDX550189-15073937
NDX550163-15073937
NDX550898-15073937
NDX550904-15073937
NDX550670-15073937
NDX550672-15073937
NDX550462-15073937
NDX550111-15073937
NDX550114-15073937
NDX550633-15073937
NDX550377-15073937
O.U.S.:
NDX550961-15073937
NDX550959-15073937
NDX550938-15073937
NDX550861-15073937
NDX550774-15073937
NDX550576-15073937
NDX550577-15073937
NDX550623-15073937
NDX550520-15073937
NDX550511-15073937
NDX550507-15073937
NDX550495-15073937
NDX550498-15073937
NDX550309-15073937
NDX550194-15073937
NDX550148-15073937
NDX550160-15073937
NDX550161-15073937
NDX550162-15073937
NDX550953-15073937
NDX550955-15073937
NDX551002-15073937
NDX550907-15073937
NDX550765-15073937
NDX550733-15073937
NDX550663-15073937
NDX550645-15073937
NDX550447-15073937
NDX550431-15073937
NDX550270-15073937
NDX550922-15073937
NDX550596-15073937
NDX550562-15073937
NDX550538-15073937
NDX550469-15073937
NDX550448-15073937
NDX550417-15073937
NDX550416-15073937
NDX550860-15073937
NDX550386-15073937
NDX550895-15073937
NDX550971-15073937
NDX550980-15073937
NDX550822-15073937
NDX550972-15073937
NDX550987-15073937
NDX550948-15073937
NDX550976-15073937
NDX550913-15073937
NDX550936-15073937
NDX550883-15073937
NDX550687-15073937
NDX550835-15073937
NDX550812-15073937
NDX550941-15073937
NDX550878-15073937
NDX550741-15073937
NDX550882-15073937
NDX550743-15073937
NDX550737-15073937
NDX550789-15073937
NDX550886-15073937
NDX550784-15073937
NDX550833-15073937
NDX550880-15073937
NDX550873-15073937
NDX550893-15073937
NDX550892-15073937
NDX550891-15073937
NDX550867-15073937
NDX550782-15073937
NDX550903-15073937
NDX550675-15073937
NDX550794-15073937
NDX550866-15073937
NDX550693-15073937
NDX550750-15073937
NDX550786-15073937
NDX550813-15073937
NDX550795-15073937
NDX550787-15073937
NDX550805-15073937
NDX550831-15073937
NDX550865-15073937
NDX550857-15073937
NDX550819-15073937
NDX550814-15073937
NDX550824-15073937
NDX550742-15073937
NDX550825-15073937
NDX550817-15073937
NDX550653-15073937
NDX550821-15073937
NDX550622-15073937
NDX550796-15073937
NDX550649-15073937
NDX550776-15073937
NDX550793-15073937
NDX550749-15073937
NDX550746-15073937
NDX550642-15073937
NDX550714-15073937
NDX550723-15073937
NDX550713-15073937
NDX550724-15073937
NDX550744-15073937
NDX550728-15073937
NDX550689-15073937
NDX550716-15073937
NDX550682-15073937
NDX550696-15073937
NDX550701-15073937
NDX550718-15073937
NDX550719-15073937
NDX550745-15073937
NDX550661-15073937
NDX550683-15073937
NDX550699-15073937
NDX550694-15073937
NDX550688-15073937
NDX550710-15073937
NDX550680-15073937
NDX550709-15073937
NDX550692-15073937
NDX550679-15073937
NDX550673-15073937
NDX550685-15073937
NDX550684-15073937
NDX550509-15073937
NDX550636-15073937
NDX550678-15073937
NDX550676-15073937
NDX550637-15073937
NDX550630-15073937
NDX550659-15073937
NDX550677-15073937
NDX550635-15073937
NDX550619-15073937
NDX550627-15073937
NDX550647-15073937
NDX550615-15073937
NDX550651-15073937
NDX550625-15073937
NDX550643-15073937
NDX550632-15073937
NDX550605-15073937
NDX550617-15073937
NDX550628-15073937
NDX550624-15073937
NDX550616-15073937
NDX550592-15073937
NDX550602-15073937
NDX550554-15073937
NDX550556-15073937
NDX550516-15073937
NDX550612-15073937
NDX550599-15073937
NDX550598-15073937
NDX550578-15073937
NDX550573-15073937
NDX550574-15073937
NDX550539-15073937
NDX550524-15073937
NDX550541-15073937
NDX550519-15073937
NDX550453-15073937
NDX550544-15073937
NDX550455-15073937
NDX550460-15073937
NDX550512-15073937
NDX550496-15073937
NDX550458-15073937
NDX550510-15073937
NDX550479-15073937
NDX550449-15073937
NDX550438-15073937
NDX550456-15073937
NDX550451-15073937
NDX550319-15073937
NDX550408-15073937
NDX550411-15073937
NDX550328-15073937
NDX550335-15073937
NDX550336-15073937
NDX550394-15073937
NDX550397-15073937
NDX550367-15073937
NDX550323-15073937
NDX550350-15073937
NDX550352-15073937
NDX550245-15073937
NDX550150-15073937
NDX550382-15073937
NDX550259-15073937
NDX550330-15073937
NDX550329-15073937
NDX550296-15073937
NDX550340-15073937
NDX550333-15073937
NDX550332-15073937
NDX550292-15073937
NDX550327-15073937
NDX550326-15073937
NDX550318-15073937
NDX550317-15073937
NDX550252-15073937
NDX550256-15073937
NDX550249-15073937
NDX550266-15073937
NDX550226-15073937
NDX550221-15073937
NDX550263-15073937
NDX550264-15073937
NDX550219-15073937
NDX550197-15073937
NDX550195-15073937
NDX550190-15073937
NDX550154-15073937
NDX550155-15073937
NDX550648-15073937
NDX550631-15073937
NDX550740-15073937
NDX550727-15073937
NDX550731-15073937
NDX550778-15073937
NDX550783-15073937
NDX550791-15073937
NDX550792-15073937
NDX550810-15073937
NDX550815-15073937
NDX550830-15073937
NDX550834-15073937
NDX550823-15073937
NDX550863-15073937
NDX550854-15073937
NDX550906-15073937
NDX550890-15073937
NDX550889-15073937
NDX550887-15073937
NDX550901-15073937
NDX550872-15073937
NDX550870-15073937
NDX550888-15073937
NDX550869-15073937
NDX550871-15073937
NDX550877-15073937
NDX550876-15073937
NDX550850-15073937
NDX550879-15073937
NDX550849-15073937
NDX550881-15073937
NDX550932-15073937
NDX550946-15073937
NDX550949-15073937
NDX550944-15073937
NDX550945-15073937
NDX550947-15073937
NDX550943-15073937
NDX550966-15073937
NDX550969-15073937
NDX550964-15073937
NDX550967-15073937
NDX550982-15073937
NDX550984-15073937
NDX550985-15073937
NDX550979-15073937
NDX550983-15073937
NDX550978-15073937
NDX550977-15073937
NDX550551-15073937
NDX550772-15073937
NDX550757-15073937
NDX550770-15073937
NDX550767-15073937
NDX550690-15073937
NDX550634-15073937
NDX550618-15073937
NDX550638-15073937
NDX550604-15073937
NDX550546-15073937
NDX550559-15073937
NDX550536-15073937
NDX550530-15073937
NDX550402-15073937
NDX550269-15073937
NDX550500-15073937
NDX550470-15073937
NDX550421-15073937
NDX550434-15073937
NDX550435-15073937
NDX550274-15073937
NDX550372-15073937
NDX550358-15073937
NDX550301-15073937
NDX551004-15073937
NDX550950-15073937
NDX550951-15073937
NDX550952-15073937
NDX550912-15073937
NDX550919-15073937
NDX550928-15073937
NDX550845-15073937
NDX550764-15073937
NDX550702-15073937
NDX550664-15073937
NDX550655-15073937
NDX550644-15073937
NDX550558-15073937
NDX550613-15073937
NDX550591-15073937
NDX550567-15073937
NDX550557-15073937
NDX550564-15073937
NDX550429-15073937
NDX550499-15073937
NDX550502-15073937
NDX550494-15073937
NDX550478-15073937
NDX550465-15073937
NDX550433-15073937
NDX550418-15073937
NDX550384-15073937
NDX550379-15073937
NDX550346-15073937
NDX550366-15073937
NDX550371-15073937
NDX550280-15073937
NDX550312-15073937
NDX550297-15073937
NDX550232-15073937
NDX550217-15073937
NDX550158-15073937
NDX550918-15073937
NDX550911-15073937
NDX550302-15073937
NDX550935-15073937
NDX550582-15073937
NDX550735-15073937
NDX550993-15073937
NDX550954-15073937
NDX550931-15073937
NDX550909-15073937
NDX550864-15073937
NDX550859-15073937
NDX550781-15073937
NDX550800-15073937
NDX550785-15073937
NDX550766-15073937
NDX550755-15073937
NDX550759-15073937
NDX550747-15073937
NDX550711-15073937
NDX550698-15073937
NDX550700-15073937
NDX550666-15073937
NDX550650-15073937
NDX550668-15073937
NDX550671-15073937
NDX550652-15073937
NDX550669-15073937
NDX550667-15073937
NDX550654-15073937
NDX550588-15073937
NDX550585-15073937
NDX550584-15073937
NDX550571-15073937
NDX550555-15073937
NDX550491-15073937
NDX550488-15073937
NDX550517-15073937
NDX550493-15073937
NDX550463-15073937
NDX550466-15073937
NDX550508-15073937
NDX550513-15073937
NDX550514-15073937
NDX550436-15073937
NDX550439-15073937
NDX550415-15073937
NDX550422-15073937
NDX550426-15073937
NDX550392-15073937
NDX550419-15073937
NDX550404-15073937
NDX550398-15073937
NDX550395-15073937
NDX550390-15073937
NDX550373-15073937
NDX550325-15073937
NDX550293-15073937
NDX550315-15073937
NDX550282-15073937
NDX550291-15073937
NDX550265-15073937
NDX550231-15073937
NDX550963-15073937
NDX550771-15073937
NDX550751-15073937
NDX550752-15073937
NDX550610-15073937
NDX550566-15073937
NDX550482-15073937
NDX550497-15073937
NDX550473-15073937
NDX550480-15073937
NDX550440-15073937
NDX550450-15073937
NDX550454-15073937
NDX550275-15073937
NDX550368-15073937
NDX550355-15073937
NDX550267-15073937
NDX550268-15073937
NDX550320-15073937
NDX550271-15073937
NDX550279-15073937
NDX550243-15073937
NDX550262-15073937
NDX550253-15073937
NDX550229-15073937
NDX550227-15073937
NDX550185-15073937
NDX550703-15073937
NDX550847-15073937
NDX550250-15073937
NDX550131-15073937
NDX550137-15073937
NDX550842-15073937
NDX550902-15073937
NDX550707-15073937
NDX550848-15073937
NDX550674-15073937
NDX550383-15073937
NDX550198-15073937
NDX550930-15073937
NDX550565-15073937
NDX550640-15073937
NDX550641-15073937
NDX550403-15073937
NDX550929-15073937
NDX551007-15073937
NDX550999-15073937
NDX550926-15073937
NDX550908-15073937
NDX550844-15073937
NDX550855-15073937
NDX550843-15073937
NDX550846-15073937
NDX550768-15073937
NDX550476-15073937
NDX550281-15073937
NDX550481-15073937
NDX550775-15073937
NDX550686-15073937
NDX550681-15073937
NDX550639-15073937
NDX550126-15073937
NDX550769-15073937
NDX550444-15073937
NDX550375-15073937
NDX550960-15073937
NDX550905-15073937
NDX550939-15073937
NDX550818-15073937
NDX550797-15073937
NDX550773-15073937
NDX550626-15073937
NDX550549-15073937
NDX550548-15073937
NDX550492-15073937
NDX550396-15073937
NDX550515-15073937
NDX550423-15073937
NDX550441-15073937
NDX550360-15073937
NDX550359-15073937
NDX550324-15073937
NDX550298-15073937
NDX550334-15073937
NDX550362-15073937
NDX550255-15073937
NDX550278-15073937
NDX550273-15073937
NDX550247-15073937
NDX550188-15073937
NDX550236-15073937
NDX550216-15073937
NDX550192-15073937
NDX550184-15073937
NDX550170-15073937
NDX550133-15073937
NDX550168-15073937
NDX550181-15073937
NDX550153-15073937
NDX550974-15073937
NDX550957-15073937
NDX550934-15073937
NDX550924-15073937
NDX550910-15073937
NDX550721-15073937
NDX550720-15073937
NDX550570-15073937
NDX550569-15073937
NDX550529-15073937
NDX550527-15073937
NDX550528-15073937
NDX550464-15073937
NDX550518-15073937
NDX550505-15073937
NDX550467-15073937
NDX551006-15073937
NDX550925-15073937
NDX550753-15073937
NDX550758-15073937
NDX550697-15073937
NDX550581-15073937
NDX550471-15073937
NDX550407-15073937
NDX550345-15073937
NDX550213-15073937
NDX550220-15073937
NDX550956-15073937
NDX550923-15073937
NDX550832-15073937
NDX550868-15073937
NDX550828-15073937
NDX550734-15073937
NDX550587-15073937
NDX550472-15073937
NDX550251-15073937
NDX550322-15073937
NDX550230-15073937
NDX550927-15073937
NDX550829-15073937
NDX550424-15073937
NDX550412-15073937
NDX550406-15073937
NDX550405-15073937
NDX550920-15073937
NDX550428-15073937
NDX550875-15073937
NDX550858-15073937
NDX550874-15073937
NDX550583-15073937
NDX550705-15073937
NDX550717-15073937
NDX550575-15073937
NDX550708-15073937
NDX550695-15073937
NDX550484-15073937
NDX550550-15073937
NDX550534-15073937
NDX550542-15073937
NDX550475-15073937
NDX550446-15073937
NDX550393-15073937
NDX550400-15073937
NDX550401-15073937
NDX550391-15073937
NDX550344-15073937
NDX550300-15073937
NDX550331-15073937
NDX550303-15073937
NDX550171-15073937
NDX550172-15073937
NDX550173-15073937
NDX550116-15073937
NDX550223-15073937
NDX550225-15073937
NDX550191-15073937
NDX550176-15073937
NDX550152-15073937
NDX550141-15073937
NDX550356-15073937
NDX550607-15073937
NDX550933-15073937
NDX550937-15073937
|
| FEI Number |
3003218906
|
Recalling Firm/
Manufacturer |
Illumina, Inc.
5200 Illumina Way
San Diego CA 92122-4616
|
| For Additional Information Contact | Adi Raval
202-629-8172 |
|---|
Manufacturer Reason
for Recall | cybersecurity vulnerability |
|---|
FDA Determined
Cause 2 | Software in the Use Environment |
|---|
| Action | On 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 Commerce | 799 instruments |
|---|
| Distribution | Worldwide 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 Cycle | TPLC 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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