The Recall Desk
ModerateFDA (Devices)·Z-2170-2018·Announced 2018-06-20

BioMérieux PREVI Color Gram Reagents Recalled Due to Temperature Excursion

BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

What this means for you

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. The hazard is a temperature excursion affecting reagent stability, which is a low-risk contamination or quality issue without reported injuries or illnesses, fitting the 'Moderate' criteria for voluntary precautionary recalls or minor quality deviations.

Plain-English summary

BioMérieux SA is recalling specific lots of PREVI Color Gram reagents (FUCHSIN-A, IODINE-B, and CRYSTAL VIOLET-C) used with the PREVI Color Gram instrument for staining bacterial and fungal microorganisms. The recall is due to a temperature excursion up to 47.8°C experienced by a shipment destined for Guadeloupe, which exceeded the product's acceptable temperature limits.

Following the detection of the temperature issue in July 2017, BioMérieux requested that its distributor in Guadeloupe place the products in quarantine. However, in November 2017, the distributor reported that the products had already been delivered to customers. The affected lots are FUCHSIN-A (Lot F89544, Exp. 13-Apr-18), IODINE-B (Lot G59407, Exp. 15-Aug-18), and CRYSTAL VIOLET-C (Lot G52306, Exp. 19-Jul-18).

Customers who have received these specific lots should stop using the reagents and contact BioMérieux or their local distributor for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have b
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Reagents
Hazard

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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