BioMerieux recalls Oxidase Reagent (ref: 55635) due to temperature excursions during shipment. Products shipped to Guadeloupe may have been exposed to 47.8°C, potentially affecting test accuracy. No remedy specified in recall notice.
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 Oxidase Reagent (ref: 55635) because shipments to Guadeloupe experienced temperature excursions up to 47.8°C, exceeding safe limits. This could affect the test's accuracy for detecting bacteria. The recall does not include a remedy.
The reagent was shipped to Guadeloupe where temperatures reached 47.8°C, which exceeds the acceptable temperature range. This could cause the reagent to degrade, potentially leading to inaccurate test results for bacterial identification.
Users of the Oxidase Reagent (ref: 55635) in Guadeloupe who received products after July 2017 are likely affected. Laboratory staff and medical professionals using the reagent for bacterial testing are at higher risk.
Check for the product name 'Oxidase Reagent (ref: 55635)' and lot number 92366601. Products were shipped to Guadeloupe between July and November 2017.
Identify if you have Oxidase Reagent (ref: 55635) with lot number 92366601.
The recall notice does not specify any remedy.
Shipments to Guadeloupe experienced temperature excursions up to 47.8°C, exceeding acceptable limits.
Products were delivered to customers in November 2017 after being quarantined in July 2017.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2172-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2172-2018 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.
