API NIT1 NIT2 Reagents Recalled Due to Improper Storage Conditions
Biomerieux is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.
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: This is an FDA Class II precautionary recall with no reported illnesses, injuries, or confirmed product failures. The hazard is theoretical—storage conditions exceeded acceptable parameters—affecting product reliability rather than posing direct safety risk. The source does not report any actual harm from use of the affected product.
Plain-English summary
Biomerieux Inc. is recalling API NIT1 NIT2 Reagents, Catalog 70442 (Batch Number 1009326520), which were distributed nationwide in the United States.
The recall was initiated because the product was stored or handled under temperature and time conditions that exceeded acceptable parameters. As a result of these out-of-range conditions, product performance cannot be guaranteed.
This product is distributed nationwide. Healthcare facilities and laboratories using this reagent batch should verify their storage conditions and product handling records.
Facilities that have this product in stock should review their records to determine if they possess or have used Batch 1009326520. Contact Biomerieux Inc. for guidance regarding the proper handling of affected product.
The recalled product
- Product
- API NIT1 NIT2 REAGENTS, CATALOG 70442
- Manufacturer
- Biomerieux Inc
- Affected units
- 1
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 03573026099671
- Batch Numbers: 1009326520
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.
See all 94 products in this recall →Related recalls
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