Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation
Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.
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: FDA Class II device recalled due to storage violation affecting product performance guarantee. This represents a risk-of-harm product affecting laboratory test reliability, though no injuries or incidents have been reported.
Plain-English summary
Biomerieux is recalling the Astute Reagent Nephrocheck Liquid Controls Kit, Catalog 500013 (Batch 22LCK0024G) distributed nationwide in the United States. The recall affects approximately 3 units.
The product was stored under temperature and time conditions that exceeded acceptable parameters. As a result, the manufacturer cannot guarantee the product will perform as intended.
Laboratory professionals using this control reagent should not rely on this batch for quality assurance testing. Users should contact Biomerieux for replacement product or disposal instructions.
The recalled product
- Product
- ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
- Manufacturer
- Biomerieux Inc
- Affected units
- 3
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 03573026565503
- Batch Numbers: 22LCK0024G
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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