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U.S. Department of Health and Human Services

Class 2 Device Recall Qiagen EZ2 Connect MDx system

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  Class 2 Device Recall Qiagen EZ2 Connect MDx system see related information
Date Initiated by Firm March 04, 2024
Date Posted April 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-1508-2024
Recall Event ID 94254
Product Classification Clinical sample concentrator - Product Code JJH
Product EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications.
Model Number: 9003230
Code Information GTIN: 04053228040576 US: P0722011M P0123035M P0323027M P0623016M P0823004M P0823051M P0523120M P0323035M P0423054M P0523114M P0823039M P0623013M P0323028M P0722022M P0223019M P1222015M P1222040M P0523110M P0523097M P0623014M P1022066M P1022069M P1022074M P0523106M P0423039M P1123016M P0423056M P0523098M P0823050M P0623008M P0223014M P0323038M P0123038M P0623015M P1022065M P0623017M P0722007M P0523118M ROW: P0823002M P0223022M P1022073M P0923045M P1123027M P1222012M P0223012M P0123082M P0823038M P0722003M P0523116M P0523112M P0523119M P0523111M P1123003M P1123001M P1123031M P1022067M P0523104M P1222039M P0923042M P1123033M P0923050M P0323034M P0223008M P0623012M P0223010M P0623005M P0623004M P0623001M P0623010M P0223016M P0223017M P0623011M P0623007M P0223023M P0223026M P0223009M P0123081M P0423040M P1123025M P1022064M P0323029M P0223021M P0523115M P1123023M P0323024M P1123026M P0722023M P0823049M P0323036M P0923044M P0823042M P0423058M P0623006M P0823052M P0623003M P0323031M P1222014M P0223011M P0923041M P0722010M P1022070M P0722006M P0722020M P0123037M P1123024M P0523117M P1123011M P0523108M P0923039M P0523096M P0323026M P0523107M P0722012M P0722008M P0923040M P0923038M P0722019M P0223013M P1123009M P0523100M P1123005M P0323025M P0223015M P0123077M P0223018M P1123004M P0722015M P0123079M P1123034M P0823041M P0523099M P0722005M P1123020M P1222011M P0123078M P0923037M P0323033M P0722009M P0523105M P0722018M P0523113M P0523103M P0722001M P0722017M P0523101M P0722014M P0323032M P0823045M P0722004M P1222038M P0523102M P1022072M P0223024M P0123036M P0523109M P0823048M P1123006M P0623002M P0323030M P0722016M P0823046M P1222013M P0823003M P0722002M P0722013M P0423041M P0423042M P0423055M
Recalling Firm/
Manufacturer		 Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact SAME
240-686-7500
Manufacturer Reason
for Recall		 Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
FDA Determined
Cause 2		 Under Investigation by firm
Action Qiagen issued Urgent Medical Device Correction letter to Lab Director/Manager, Medical Director, Risk Manager, Safety Officer on 3/4/24 via email. Letter states reason for recall, health risk and action to take: Complete the Acknowledgment of Receipt promptly and return to quality.communications@qiagen.com. Should the error described above occurs, please perform the following actions: o Switch off the instrument and disconnect from the power supply. o Remove any onboard samples and perform decontamination procedure of the instruments as described in the user manual. o Call your local QIAGEN Technical Service or the Commercial Partner responsible for QIAGEN products in your country. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: " Telephone: (800) 362-7737 " Email: TechService-NA@qiagen.com
Quantity in Commerce 168 units: 38 units US; 130 units OUS
Distribution Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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