BioMerieux NucliSENS Magnetic Extraction Reagents Recall: Low Temperature Risk
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.
Lower-risk recall
Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69855-biomerieux-nuclisens-magnetic-extraction-reagents-recall-low-temperature-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69855-biomerieux-nuclisens-magnetic-extraction-reagents-recall-low-temperature-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0218-2019
Cite this page
“BioMerieux NucliSENS Magnetic Extraction Reagents Recall: Low Temperature Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69855-biomerieux-nuclisens-magnetic-extraction-reagents-recall-low-temperature-risk. Based on FDA recall #Z-0218-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0218-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check the lot number on the reagent container. Affected lots include Reference # 200293, Lot # 17121501, with an expiration date of 11/28/2018.
- Brand
BioMerieux- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the reagent container to determine if it matches the affected lot numbers: Reference # 200293, Lot # 17121501.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Maryland, Massachusetts, Ohio, Oregon, Texas, Washington.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from this product?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-0218-2019 (September 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0218-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.