Agency classClass IIOur severity:High FDA (Devices)·Z-0810-2023·Announced 2023-01-11

API JAMES 2AMP Clinical Diagnostic Device Recall Due to Storage Condition Violations

Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device whose failure to perform could lead to diagnostic errors and patient harm. No illnesses or injuries have been reported, but the device is being recalled due to storage condition violations that compromise performance specifications.

Plain-English summary

Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices nationwide. The recall was issued due to storage condition violations where the product was exposed to temperatures and duration outside manufacturer specifications.

When storage conditions exceed specified limits, product performance cannot be guaranteed. Users should not rely on affected units for clinical testing or diagnosis.

Affected units are identified by UDI/DI 03573026099893 and batch number 1009360510. If you are using this product, contact the manufacturer for instructions on how to proceed.

Healthcare facilities and laboratories that received this product should immediately cease use of affected units and contact Biomerieux Inc for replacement or further guidance.

The recalled product

Product: API JAMES 2AMP, CATALOG 70542
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Diagnostic
Hazard: storage-failure
performance-degradation
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 03573026099893
Batch Numbers: 1009360510

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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