TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion
Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.
What this means for you
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 device recall with no reported illnesses or injuries. The hazard is performance degradation of a critical laboratory control material that could compromise downstream test reliability, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc. is recalling the TEMPO REAGENTS TEMPO CONTROL KIT, Catalog 80000, due to storage temperature and time excursions that prevent guaranteeing product performance.
The recall affects batch number 1009477900, which was distributed nationwide in the United States. This product is a control kit used in laboratory testing to verify assay performance and result reliability.
Because temperature and time storage conditions were exceeded, the performance of these reagents cannot be guaranteed. This degradation may affect the reliability of test results that depend on this control material for validation.
Laboratories that have received affected batch 1009477900 should discontinue use and contact Biomerieux Inc. for replacement product or additional guidance.
The recalled product
- Product
- TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
- Manufacturer
- Biomerieux Inc
- Affected units
- 2
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 03573026128142
- Batch Numbers: 1009477900
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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