The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2172-2018·Announced 2018-06-20

BioMérieux Recalls Oxidase Reagent Due to Temperature Excursion in Guadeloupe

BioMérieux is recalling Oxidase Reagent (ref: 55635) in Guadeloupe after a shipment experienced temperature excursions up to 47.8°C, exceeding acceptable limits.

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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The hazard involves a temperature excursion that may compromise the reagent's efficacy, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

BioMérieux SA is recalling 4 boxes of Oxidase Reagent (ref: 55635), containing 50 bottles of 0.75 mL each, with lot number 92366601. This product is a medical device used to detect the production of the enzyme cytochrome oxidase by bacteria, aiding in the differentiation and identification of microorganisms for disease diagnosis.

The recall was initiated because a shipment to Guadeloupe suffered temperature excursions up to 47.8°C, which exceeded the acceptable limits for the product. After the issue was detected, Global Supply Chain QA requested that the BioMérieux distributor in Guadeloupe place the products in quarantine in July 2017. However, after several reminders, the distributor informed the company in November 2017 that the products had already been delivered to customers.

The affected products were distributed internationally, specifically to customers in Guadeloupe. Users of this product should stop using the recalled lot and contact their supplier or BioMérieux for further instructions on disposal or replacement.

The recalled product

Product
Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A…
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Reagent
Hazard

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 (1)

  • Oxidase Reagent (ref: 55635): Lot number 92366601

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 9 recalled by BioMerieux SA 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 9 products in this recall →

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