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.
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 2/5 (Moderate).
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 →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- 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
Same hazard · storage exceedance
See all →- HighVIDAS BRAHMS Procalcitonin Test System Recalled for Storage Condition Failure
FDA (Devices) · 2023-01-11
Similar recalls
- ModerateHardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates
FDA (Devices) · 2015-09-02
- HighAmeditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance
FDA (Devices) · 2020-10-07
- HighbioMerieux Recalls chromID Salmonella Agar Due to Colony Color Issues
FDA (Devices) · 2013-11-06
- HighPTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk
FDA (Devices) · 2020-01-29
- ModeratePrescription thyroid drug recalled due to temperature storage deviation
FDA (Drugs) · 2024-01-03
- ModerateBiomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design Files
FDA (Devices) · 2020-06-17