FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance
Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.
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: FDA Class II medical device recall for diagnostic equipment cleaning solution. While no illnesses or injuries have been reported, performance degradation affecting laboratory diagnostic equipment represents a risk-of-harm scenario due to potential for compromised test accuracy.
Plain-English summary
Biomerieux Inc is recalling PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (Catalog 29588) distributed nationwide in the United States.
The recall was initiated because temperature and time storage conditions were exceeded during handling or distribution. As a result, the manufacturer cannot guarantee the product's performance.
Laboratories and healthcare facilities using this product batch (229478) should contact Biomerieux Inc for instructions on replacement or return.
The recalled product
- Product
- PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
- Manufacturer
- Biomerieux Inc
- Hazard
- temperature-exceedance
- performance-degradation
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 03573026263164
- Batch Numbers: 229478
Distribution
Distributed nationwide across the United States.
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