The 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.
FDA Recall Z-1742-2020 · Posted None
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Recalling FirmBiomerieux Inc
Recall StatusOpen, Classified
Product CodeN/A
Date Initiated2020-03-11
Product Quantity1698 cartons (15,940 cards)
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).
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Firm Action
On 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.
Root Cause
Under Investigation by firm
Distribution Pattern
No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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