Agency classClass IIOur severity:High FDA (Devices)·Z-0793-2023·Announced 2023-01-11

Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage

Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product 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 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 is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—improper storage conditions may have degraded the diagnostic reagent's performance, creating a risk of inaccurate test results, but no actual harm has been reported.

Plain-English summary

Biomerieux Inc is recalling PREVI COLOR GRAM REAGENT IODINE-B (NA), Catalog 29586, a diagnostic reagent used in medical laboratory testing. The recalled product was distributed nationwide in the United States. The affected batch is numbered 230438.

The product was exposed to storage temperature and time conditions that exceeded acceptable ranges. Because of this exposure, the manufacturer cannot guarantee that the product will perform as intended.

Healthcare facilities and laboratory personnel using this reagent should discontinue use of the recalled batch and contact Biomerieux Inc for replacement or further guidance regarding product substitution.

The recalled product

Product: PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
Manufacturer: Biomerieux Inc
Category: Medical Device — Diagnostic Reagent
Hazard: reagent-degradation
diagnostic-inaccuracy
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 03573026263140
Batch Numbers: 230438

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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