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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 ASTP652

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 Class 2 Device Recall VITEK 2 ASTP652see related information
Date Initiated by FirmMarch 11, 2020
Create DateApril 17, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1742-2020
Recall Event ID 85209
510(K)NumberK053097 
Product Classification unknown device name - Product Code N/A
ProductThe VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Code Information VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
FEI Number 1950204
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
Manufacturer Reason
for Recall		There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
FDA Determined
Cause 2		Under Investigation by firm
ActionOn March, 11, 2020 a notification letter was issued to the impacted subsidiaries which included a Customer Letter to be translated into local language. The customer letter instructs the customer to stop the use of the impacted AST-P652 lot, to complete the attached Acknowledgement Form, and return any affected unused product to their local bioMrieux representative as soon as possible.
Quantity in Commerce1698 cartons (15,940 cards)
DistributionNo distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
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.
510(K) Database510(K)s with Product Code = N/A
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