Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The issue is a documentation error in the product insert.
Plain-English summary
Biomerieux Inc is recalling 1,035 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144). The affected lots are 746382820 (exp. 6/7/17) and 746386520 (exp. 7/14/17). These products were distributed in the Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
The recall was initiated because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin. 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 Staphyloccus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents.
Clinical laboratories should stop using the affected test cards and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- 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 Staphylo
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 1,035
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 746382820 exp. 6/7/17 and 746386520 exp. 7/14/17 .
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02