Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—improper storage conditions may have degraded the diagnostic reagent's performance, creating a risk of inaccurate test results, but no actual harm has been reported.
Plain-English summary
Biomerieux Inc is recalling PREVI COLOR GRAM REAGENT IODINE-B (NA), Catalog 29586, a diagnostic reagent used in medical laboratory testing. The recalled product was distributed nationwide in the United States. The affected batch is numbered 230438.
The product was exposed to storage temperature and time conditions that exceeded acceptable ranges. Because of this exposure, the manufacturer cannot guarantee that the product will perform as intended.
Healthcare facilities and laboratory personnel using this reagent should discontinue use of the recalled batch and contact Biomerieux Inc for replacement or further guidance regarding product substitution.
The recalled product
- Product
- PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
- Manufacturer
- Biomerieux Inc
- Affected units
- 10
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 03573026263140
- Batch Numbers: 230438
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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