The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2171-2018·Announced 2018-06-20

BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion

BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion 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 is a temperature excursion that may compromise product efficacy, but no injuries or illnesses are reported in the source text.

Plain-English summary

BioMérieux SA is recalling 8 boxes of Color Gram 2 (COLOR GRAM 2 - F) stains, specifically lot number G64508 (ref: 55542). These products are used to stain bacterial and fungal microorganisms for direct examination according to the Gram method.

The recall was initiated because a shipment to Guadeloupe suffered a temperature excursion 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, the distributor informed the company in November 2017 that the products had already been delivered to customers.

The affected products were distributed internationally, with the specific incident involving the Guadeloupe market. Customers who possess this specific lot number should stop using the product and contact their supplier or BioMérieux for further instructions.

The recalled product

Product
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in…
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Reagents
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)

  • Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508

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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