BioMerieux recalls Color Gram 2 (COLOR GRAM 2 - F) stains due to temperature excursions during shipment, potentially causing contamination. Affected lots were shipped to Guadeloupe in 2017 and may have been delivered to customers.
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 Color Gram 2 (COLOR GRAM 2 - F) bacterial and fungal staining solutions because they were exposed to high temperatures during shipment in Guadeloupe in 2017. This could lead to contamination risks if the stains are used in medical testing.
The stains were exposed to temperatures up to 47.8°C during shipment in Guadeloupe, exceeding safe limits. This could cause the product to become contaminated, potentially leading to inaccurate test results or health risks if used improperly.
Healthcare professionals using Color Gram 2 stains for medical testing in labs or clinics may be affected. Patients relying on these stains for accurate diagnostic results are at risk if the product is contaminated.
Check for lot number G64508 on the Color Gram 2 (COLOR GRAM 2 - F) packaging. Products were shipped to Guadeloupe in 2017 and may have been delivered to customers.
Look for lot number G64508 on the Color Gram 2 (COLOR GRAM 2 - F) packaging to confirm if it is affected.
The Color Gram 2 stains were exposed to high temperatures during shipment in Guadeloupe in 2017, which could cause contamination.
Check the lot number on the packaging. If it is G64508, contact BioMerieux for guidance.
The recall record does not specify a remedy.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2171-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2171-2018 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.
