PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure
Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised 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, injuries, or test failures. The hazard is theoretical—temperature and time exposure during storage may have compromised product performance, but actual harm has not been documented. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Biomerieux Inc is recalling PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML (Catalog T8035) distributed nationwide in the United States. The affected product is identified by UDI/DI 03573026321420 and batch number 1009564750.
The manufacturer determined that the product was exposed to temperature and time conditions exceeding acceptable parameters. Under these conditions, product performance cannot be guaranteed. This sterile phosphate buffer is used in laboratory and microbiological testing applications.
The recalled product
- Product
- PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
- Manufacturer
- Biomerieux Inc
- Hazard
- temperature-time-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 03573026321420
- Batch Numbers: 1009564750
Distribution
Distributed nationwide across the United States.
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