Biomerieux PPM Culture Plates Recalled for Storage Stability Issues
Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.
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 for a medical device where performance cannot be guaranteed due to storage condition excursions. The hazard is a risk-of-harm product (device malfunction), but no illnesses or injuries have been reported. Per the rubric, theoretical hazards without reported harm score at most 3.
Plain-English summary
Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM culture plates (UDI/DI 03661901005531, Batch Number 2134340) distributed nationwide in the United States.
The recall was initiated because these devices were exposed to storage temperatures and time durations that exceeded acceptable ranges. Due to these excursions, the product's performance cannot be guaranteed.
This product is a culture plate medical device. Improper storage conditions may affect the device's ability to perform as intended. Institutions that have received this product should contact Biomerieux Inc regarding this recall.
The recalled product
- Product
- PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device — Culture Plate
- Hazard
- device-malfunction
- storage-excursion
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 03661901005531
- Batch Numbers: 2134340
Distribution
Distributed nationwide across the United States.
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