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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 100
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.
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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