Recall Z-1640-2016 ยท LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 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 Informati
| Date | May 11, 2016 (initiated Feb 24, 2016) |
| Status | Terminated |
| Reason | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| Root cause | Labeling Change Control |
| 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. |
| Quantity | 180 kits |
| Distribution | Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.