Agency classClass IIOur severity:High FDA (Devices)·Z-0801-2023·Announced 2023-01-11

Medical device diagnostic plates recalled for storage condition violations

Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, 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 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: This Class II medical device recall involves a diagnostic product where storage degradation may compromise test performance and reliability. Although no test failures or patient injuries have been reported, the product is critical for clinical diagnosis, and unreliable results could affect patient care decisions.

Plain-English summary

Biomerieux Inc is recalling PPM Clinical Craponne Clinical Chromid Candida 20 Plates (Catalog 43631) because storage temperature and time parameters were exceeded for the affected batch.

When storage conditions are not maintained within specifications, the performance and reliability of diagnostic test plates cannot be guaranteed. These plates are used to identify Candida species in clinical laboratory settings, and degraded product performance could result in unreliable test results.

The recall affects 10 units with Batch Number 1009532350, distributed nationwide throughout the United States.

The recalled product

Product: PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Laboratory / Diagnostic
Hazard: storage-degradation
test-failure
Affected units: 10

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 03573026118969
Batch Numbers: 1009532350

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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