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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK

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 Class 2 Device Recall VITEKsee related information
Date Initiated by FirmNovember 09, 2022
Date PostedJanuary 04, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0789-2023
Recall Event ID 91148
Product Classification Kit, identification, yeast - Product Code JXB
ProductVITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Code Information UDI/DI 03573026131937, Batch Numbers: 2432261103
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactClinical 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
ActionBiomerieux 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 bioMrieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.
Quantity in Commerce14 units
DistributionUS Nationwide distribution.
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.
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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