Recalls / —

—#144600

Product

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 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 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17.

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 #144600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.