Biomerieux Inc Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 41857
Biomerieux Inc Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 41857 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Biomerieux Inc; Product: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Posit
| Recalling firm | Biomerieux Inc |
|---|---|
| Product | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 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. |
| Reason for recall | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey. |
| Recall initiated | 20160224 |
| Recall number | Z-1641-2016 |
| Category | device |
| State | MO |
| Country | United States |
$29/mo
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