Agency classClass IIOur severity:High FDA (Devices)·Z-0794-2023·Announced 2023-01-11

FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance

Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.

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 recall for diagnostic equipment cleaning solution. While no illnesses or injuries have been reported, performance degradation affecting laboratory diagnostic equipment represents a risk-of-harm scenario due to potential for compromised test accuracy.

Plain-English summary

Biomerieux Inc is recalling PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (Catalog 29588) distributed nationwide in the United States.

The recall was initiated because temperature and time storage conditions were exceeded during handling or distribution. As a result, the manufacturer cannot guarantee the product's performance.

Laboratories and healthcare facilities using this product batch (229478) should contact Biomerieux Inc for instructions on replacement or return.

The recalled product

Product: PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
Manufacturer: Biomerieux Inc
Category: Medical Device — Laboratory Equipment Cleaning Solution
Hazard: temperature-exceedance
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 03573026263164
Batch Numbers: 229478

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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Same hazard · temperature exceedance