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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 REAGENT

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  Class 2 Device Recall VITEK 2 REAGENT see related information
Date Initiated by Firm November 09, 2022
Date Posted January 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-0857-2023
Recall Event ID 91148
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
Product VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Code Information UDI/DI 03573026618940, Batch Numbers: 3122253113
Recalling Firm/
Manufacturer
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Clinical Customer Support
800-682-2666
Manufacturer Reason
for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
FDA Determined
Cause 2
Storage
Action Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement or credit for the destroyed product. b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement Form. 4. Please store this letter with your bioM¿rieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioM¿rieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.
Quantity in Commerce 50 units
Distribution US Nationwide distribution.
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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