PPM Clinical CHROMID MRSA diagnostic product recalled due to storage condition exceedance
Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.
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: FDA Class II precautionary recall with no reported performance failures or illnesses. Storage parameters exceeded and product performance cannot be guaranteed, fitting the rubric category of voluntary precautionary recalls.
Plain-English summary
Biomerieux Inc is recalling batch 1009550310 of PPM Clinical CHROMID MRSA S. aureus 20PLT US (catalog 414524), a bacterial identification medium used in clinical laboratories. The product was distributed nationwide.
The recall was initiated because temperature and time storage parameters were exceeded during the product's handling. When storage conditions are not maintained within specification, the product's diagnostic performance cannot be guaranteed.
The recalled product
- Product
- PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 6
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 03573026420758
- Batch Numbers: 1009550310
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 · storage exceedance
See all →- HighVIDAS BRAHMS Procalcitonin Test System Recalled for Storage Condition Failure
FDA (Devices) · 2023-01-11