—#144604

Product

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with 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: LTW — Susceptibility Test Cards, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lots 746382820 exp. 6/7/17 and 746386520 exp. 7/14/17 .

Why it was recalled

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioMrieux representative.

Recalling firm

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

Distribution

Distribution pattern: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Timeline

Recall initiated: 2016-02-24
Posted by FDA: 2016-05-11
Terminated: 2018-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.