Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-1647-2016 · Posted 2016-05-11

Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLTW
Date Initiated2016-02-24
Date Terminated2018-03-08
Product Quantity1,035 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.

↑