—#115837

Product

bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.

FDA product code: LTW — Susceptibility Test Cards, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: lot number: 540274420

Why it was recalled

The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

Root cause (FDA determination)

Error in labeling

Action the firm took

bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.

Recalling firm

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

Distribution

Distribution pattern: Distributed only in HI.

Timeline

Recall initiated: 2013-02-06
Posted by FDA: 2013-03-27
Terminated: 2013-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.