PPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect
Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.
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 for a risk-of-harm medical device with no reported illnesses or injuries. The storage defect could compromise product performance in laboratory testing, but no actual harm has been documented.
Plain-English summary
Biomerieux Inc. is recalling PPM Lombard Products TSA 3P W Neutralizers (Catalog 423723, Batch 1009552660), affecting 74 units distributed nationwide in the United States.
The product was stored under conditions where temperature and time parameters exceeded acceptable ranges. Due to these storage excursions, product performance cannot be guaranteed.
This is a Class II medical device recall issued by the FDA. Customers who have received affected units should discontinue use and contact Biomerieux Inc. for replacement or refund instructions.
More details are available through FDA recall number Z-0858-2023.
The recalled product
- Product
- PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
- Manufacturer
- Biomerieux Inc
- Affected units
- 74
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 03573026618018
- Batch Numbers: 1009552660
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.
See all 94 products in this recall →Related recalls
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