bioMerieux Recalls chromID Salmonella Agar Due to Colony Color Issues
bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.
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: The recall involves a high-risk pathogen (Salmonella) and a diagnostic medium where failure could lead to missed detections, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
bioMerieux, Inc. is voluntarily recalling 90 units of chromID Salmonella Agar, Reference No. 43621. This product is a selective isolation and differentiation medium used for the detection of Salmonella in human specimens. The affected lots are 1002234210 and 1002300040, and the product was distributed nationwide.
The recall was initiated due to complaints that Salmonella strains growing on this medium produced uncharacteristic white-colored colonies instead of the expected pale pink to mauve colored colonies. This deviation in colony color could potentially lead to Salmonella colonies not being detected during laboratory testing.
Healthcare facilities and laboratories that possess the affected product should stop using it immediately. Users should contact bioMerieux, Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 90
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)
- Lot 1002234210 and 1002300040
Distribution
Distributed nationwide across the United States.
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