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
- Hazard
- performance-degradation
- storage-damage
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.
Related recalls
Same category
- SevereMedline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- SevereMedline convenience kits recalled for unapproved syringe design changes
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01