Lower riskMedical device recall · FDA · Published October 18, 2017
BioMerieux NucliSENS Lysis Buffer Extended Lot 76675 Recall: Test Inhibition Risk
BioMerieux recalls specific lot of NucliSENS Lysis Buffer Extended for RES 76675 due to potential test inhibition from heme residue, risking inaccurate PCR results.
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
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Contact the company
📍Recalling firmBioMerieux SAChemin De L'Orme · Marcy L'Etoile, France
“BioMerieux NucliSENS Lysis Buffer Extended Lot 76675 Recall: Test Inhibition Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72814-biomerieux-nuclisens-lysis-buffer-extended-lot-76675-recall-test-inhibition. Based on FDA recall #Z-0086-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2018%22&limit=1).
The FDA announced on 2017-10-18 that BioMerieux SA voluntarily recalled NucliSENS Lysis Buffer Extended lot for RES 76675. The hazard is that residual heme may inhibit PCR reactions, causing uninterpretable or invalid test results.
How to tell if you have it
Brand: BioMerieux
Product: NucliSENS Lysis Buffer Extended lot for RES 76675
REF: 200292
Lot: 17022802
Expiration Date: 01/28/2019
Units affected: 911
The hazard
Elute may become colored due to residual heme from whole blood or dried spot samples. This can inhibit PCR reactions and result in uninterpretest results. If an Internal Control is used, it could also be inhibited, invalidating test results.
Context
GovInfoNow's records show BioMerieux SA has five other recalls on record since 2018-03-23. Other recent recalls of similar products include BioMerieux MYLA Software Versions 4.7-4.8.2 Recall (2021-09-02), BioMerieux MYLA Software Recall (2021-06-22), and BioMerieux NucliSENS Magnetic Extraction Reagents Recall (2018-09-17). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04), and Immuno-Mycologics Immy Neutralization Buffer Recall (2026-03-26).
How to tell if you have this one
Check for the lot number 17022802 on the packaging. This extended lot was sold with expiration date 01/28/2019 for RES 76675.
Brand
BioMerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot number 17022802 on the packaging to confirm if the product is recalled.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Distributed domestically to MD, CO, and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Maryland, Ohio.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0086-2018 (October 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0086-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.