BioMerieux recalls NucliSENS Magnetic Extraction Reagents from specific lots due to potential performance issues from low temperatures. Affected units may not function correctly if stored in cold environments.
Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
BioMerieux is recalling certain lots of NucliSENS Magnetic Extraction Reagents because low temperatures during shipping could affect their performance. This means the reagents might not work properly if they were stored in cold conditions.
The data loggers indicate that one shipment to the U.S. was exposed to low temperatures. This could cause the reagents to malfunction or not perform as intended, potentially leading to inaccurate test results.
Users of these reagents in laboratories or clinical settings who purchased the specific lot numbers mentioned in the recall. Those who stored the product in cold environments are at slightly higher risk.
Check the lot number on the reagent container. Affected lots include Reference # 200293, Lot # 17121501, with an expiration date of 11/28/2018.
Look for the lot number on the reagent container to determine if it matches the affected lot numbers: Reference # 200293, Lot # 17121501.
The recall is due to data loggers showing that one shipment to the United States experienced low temperatures that may impact the product's performance.
Check the lot number on the reagent container. If it matches Reference # 200293, Lot # 17121501, contact BioMerieux for further instructions.
The recall indicates a potential performance issue, but there is no mention of injury risk. The hazard is limited to possible malfunction in laboratory use.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0218-2019 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-0218-2019 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.