—#144536

Product

VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. 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 the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot/Serial: 485368220 Expiry: 12-JAN-17

Why it was recalled

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

Root cause (FDA determination)

Other

Action the firm took

Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 2016, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. For the referenced test kit (VITEK 2 ASTP605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory. o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new ASTP605 lot number. Customers were instructed tostore the letter with their bioMrieux instrument documentation. Complete the attached Acknowledgement Form and return it to their local bioMrieux representative. For questions regarding this recall call 314-731-8526.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution to China Taiwan region; No US/military/government distribution.

Timeline

Recall initiated: 2016-02-24
Posted by FDA: 2016-05-03
Terminated: 2017-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.