—#180309

Product

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 product code: N/A
510(k) numbers: K053097
Affected lot / code info: VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021

Why it was recalled

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). .

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

Distribution pattern: No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium

Timeline

Recall initiated: 2020-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180309. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.