Medical device TSA culture medium recalled due to storage temperature excursion
Biomerieux Inc. is recalling PPM Lombard TSA culture medium nationwide due to storage temperature excursion. The product may not perform to specification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. The hazard is theoretical—product performance cannot be guaranteed due to storage temperature and time excursions—meeting the criteria for Moderate severity.
Plain-English summary
Biomerieux Inc. is recalling PPM Lombard Products TSA 10PLT (Catalog M1040) with batch number 1009527240. The product was distributed nationwide in the United States.
The recall was initiated because the product was exposed to temperatures and durations outside the manufacturer's specifications. As a result, the manufacturer cannot guarantee that the product will perform as intended.
Users of this product should discontinue use and contact Biomerieux Inc. for instructions regarding replacement or alternative products.
The recalled product
- Product
- PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
- Manufacturer
- Biomerieux Inc
- Affected units
- 1
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 03573026320362
- Batch Numbers: 1009527240
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
Same manufacturer · Biomerieux Inc
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · performance degradation
See all →- ModerateSolar GI System Water Perfusion Units Recalled Due to Moisture Accumulation
FDA (Devices) · 2026-07-08
- HighPPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect
FDA (Devices) · 2023-01-11
- ModeratePPM Clinical Chromid VRE Culture Media Recalled for Storage Excursion
FDA (Devices) · 2023-01-11
- ModerateBioball Fungal Reference Standard Recalled for Temperature Storage Issues
FDA (Devices) · 2023-01-11
- HighVITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance
FDA (Devices) · 2023-01-11