Clinical Reagent Vitek MS-FA Recalled Due to Storage Condition Violations
Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.
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 recall due to storage condition violations that degrade reagent performance. No illnesses or injuries have been reported; the hazard is performance degradation rather than direct harm.
Plain-English summary
Biomerieux Inc is recalling VITEK MS-FA Clinical Reagent (Catalog 411072) distributed in the United States. This reagent is used in clinical laboratory testing.
The reagent was stored at temperatures and for durations outside manufacturer specifications. As a result, the manufacturer can no longer guarantee the product's performance in clinical use.
The recall affects 29 units with batch number 1009346190 that were distributed to healthcare facilities and laboratories nationwide.
Healthcare providers and laboratory directors should verify whether they have received the affected batch. Those with the recalled product should contact Biomerieux Inc for instructions on return or replacement.
The recalled product
- Product
- VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
- Manufacturer
- Biomerieux Inc
- Affected units
- 29
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 03573026362843
- Batch Numbers: 1009346190
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 · reagent degradation
See all →- ModerateEMD Millipore Issues Recall of Schiff Reagent Hotchkiss-McManus for Discoloration
FDA (Devices) · 2024-03-06
- HighVITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion
FDA (Devices) · 2023-01-11
- HighVITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance
FDA (Devices) · 2023-01-11
- HighMedical Diagnostic Reagent Recalled Due to Storage Temperature Damage
FDA (Devices) · 2023-01-11
- HighK-ASSAY IgA Immunoturbidimetric Assay reagent recalled for cloudiness affecting test performance
FDA (Devices) · 2022-11-30