BioMerieux recalls PREVI Color Gram dyes due to temperature excursions in shipments to Guadeloupe, potentially affecting product safety.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
BioMerieux is recalling PREVI Color Gram dyes that were shipped to Guadeloupe in 2017. The dyes may have been exposed to temperatures up to 47.8°C, which could compromise their safety and effectiveness.
The dyes were shipped to Guadeloupe and experienced temperature excursions up to 47.8°C, exceeding acceptable limits. This could lead to improper staining results or potential safety issues for users.
Users of the PREVI Color Gram dyes for bacterial and fungal staining in medical labs in Guadeloupe are most at risk. The recall affects specific lot numbers sold in that region.
Check for lot numbers: IODINE-B (G59407, expires 15-Aug-18), CRYSTAL VIOLET-C (G52306, expires 19-Jul-18), and FUCHSIN-A (F89544, expires 13-Apr-18). These dyes were sold in shipments to Guadeloupe in 2017.
Identify the lot numbers of the dyes: IODINE-B (G59407), CRYSTAL VIOLET-C (G52306), and FUCHSIN-A (F89544).
The dyes were shipped to Guadeloupe and experienced temperature excursions up to 47.8°C, exceeding acceptable limits.
IODINE-B (lot G59407, expires 15-Aug-18), CRYSTAL VIOLET-C (lot G52306, expires 19-Jul-18), and FUCHSIN-A (lot F89544, expires 13-Apr-18).
Check for the specific lot numbers listed above, which were sold in shipments to Guadeloupe in 2017.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2170-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2170-2018 from BioMerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
