Susceptibility test cards recalled over false resistant antibiotic results
bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the cards may give false resistant antibiotic results, and no injuries are reported.
Plain-English summary
VITEK 2 Gram-negative Susceptibility Cards containing Polymyxin B (pb02n), Ceftazidime/avibactam (cza02n), Meropenem/Vaborbactam (mev01n), Imipenem (ipm05n) and Imipenem/Relebactam (ipr01n) are being recalled by Biomerieux Inc. The affected card names and product references, including AST-N399, AST-N402, AST-N403, AST-N404 and AST-N405, are listed in the enforcement record.
The record states there is a potential risk of quality control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations, and that the issue may lead to QC failure or false resistant results.
The record lists 2,668,954 total and covers all lot codes of the identified Gram-negative AST test kits. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
A false resistant result can change which antibiotic a patient is given. The enforcement record reports no injuries. Laboratories should follow bioMerieux's instructions.
The recalled product
- Product
- VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403…
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,668,954
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)
- All lot codes of the identified Gram-negative AST test kits.
Distribution
Distributed nationwide across the United States.
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