Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Biomerieux Inc is recalling 495 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951). The recall involves specific lots with expiration dates of 2/25/16, 4/14/16, and 8/4/17. 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 Staphylo spp., Enterococcus spp., and S. agalactiae to antimicrobial agents.
This recall is classified as Class I by the FDA. Users should contact Biomerieux Inc for further instructions regarding the affected lots.
The recalled product
- Product
- 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…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 495
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 (3)
- Lots 736336020 exp. 2/25/16
- 736340920 exp. 4/14/16
- and 736388620 exp. 8/4/17.
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.
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