Listeria Detection Test Strips Recalled for Unreliable Performance
Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.
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: This is a Class II FDA recall involving Listeria, a high-risk pathogen. Although no illnesses or injuries have been reported, the risk of detection failure could result in serious harm. This matches the rubric criterion for High severity: 'high-risk pathogens (Listeria...) without reported illness.'
Plain-English summary
Biomerieux Inc. is recalling API LISTERIA 10 STRIPS+10 MEDIA, Catalog 10300, Batch Number 1009418280, distributed nationwide in the United States.
The affected test strips were exposed to temperature and time conditions exceeding specified storage parameters during distribution. The manufacturer has stated that product performance cannot be guaranteed as a result of these storage exceedances.
The recall applies to all units bearing batch number 1009418280. Laboratories and facilities in possession of this batch should discontinue use immediately.
For information on replacement units or further guidance, contact Biomerieux Inc. directly.
The recalled product
- Product
- API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
- Manufacturer
- Biomerieux Inc
- Affected units
- 5
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 (2)
- UDI/DI 03573026035587
- Batch Number 1009418280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 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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