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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 FirmJune 04, 2026
Date PostedJuly 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2715-2026
Recall Event ID 99213
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
ProductVITEK 2 AST-N447 TEST KIT Product reference 424620
Code Information Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
FEI Number 1950204
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactbioMerieux Customer Service Center
314-731-8526
Manufacturer Reason
for Recall		Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
FDA Determined
Cause 2		Process change control
ActionFirm began notifying customers on June 4, 2026. Customers are instructed to dispose of pouches from the affected lot (Ref 424620, Lot 0853293604). Customer may choose to inspect each pouch in their inventory and only dispose of those with "P7" on the label, or they may choose to dispose of all cards from Lot 0853293604 in their inventory. Based on individual customer policy, customers may wish to perform retrospective review of resistant results. Customers should distribute the information to all appropriate personnel in their laboratory. If product was transferred or further distributed, customer should notify downstream users/accounts.
Quantity in Commerce45,900 cards
DistributionInternational distribution to the countries of Belgium and the Netherlands.
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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