Biomerieux Recalls VITEK 2 Anaerobic Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Anaerobic and Corynebacteria identification cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, and no illnesses are reported.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Anaerobic and Corynebacteria identification cards (ANC), REF 21347. The recall involves 6,316 cartons, with 20 cards per carton. The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.
The recall was initiated because the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency. The affected lots have codes 2440168103 (dated 13/May/18), 2440202103 (dated 16/Jun/18), and 2440293203 (dated 15/Sep/18).
Users of these identification cards should stop using the affected lots and contact Biomerieux Inc for further instructions or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 6,316
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)
- 2440168103 13/May/18 2440202103 16/Jun/18 2440293203 15/Sep/18
Distribution
Part of a larger recall action
This product is one of 187 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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