Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 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 Recall Z-1639-2016 · Posted 2016-05-11
Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLTW
Date Initiated2016-02-24
Date Terminated2018-03-08
Product Quantity495 kits
Reason for Recall
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Firm Action
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.
Root Cause
Labeling Change Control
Distribution Pattern
Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.