Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0804-2023·Announced 2023-01-11

C. difficile diagnostic kit recalled due to storage temperature deviation

Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.

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 with no reported illnesses or injuries. The primary hazard is storage-condition deviation that may compromise diagnostic test performance and reliability; however, this is a precautionary recall without confirmed patient harm or adverse test results.

Plain-English summary

Biomerieux Inc is recalling the PPM CLINICAL CRAPONNE CHROMID C. DIFFICILE diagnostic kit (Catalog 43871) distributed nationwide in the United States. The recall is being issued because some units were stored outside specified temperature and time parameters, which may compromise the product's ability to perform as intended.

The affected batch is identified as Batch Number 1009501430, with UDI/DI 03573026316969. Healthcare facilities and laboratories that received affected units should discontinue use and contact Biomerieux for replacement units or further instructions.

Although no illnesses or injuries have been reported, the storage deviation means the diagnostic test's accuracy cannot be guaranteed. Healthcare providers should be aware that test results from potentially affected units may not be reliable. Patients who have been tested with potentially affected units may wish to consult with their healthcare provider to determine if retesting is necessary.

The recalled product

Product: PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
Manufacturer: Biomerieux Inc
Category: Medical Device — Diagnostic Test
Hazard: storage-temperature-deviation
diagnostic-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 03573026316969
Batch Numbers: 1009501430

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 →

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