Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0816-2023·Announced 2023-01-11

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.

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 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
Category: Medical Device — Clinical Reagent
Hazard: reagent-degradation
storage-violation
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 →

Same manufacturer · Biomerieux Inc

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