NucliSENS Lysis Buffer Extended lot for RES 76675 — Class II medical device recall Z-0086-2018
Terminated recall by BioMerieux SA, reported 2017-11-15, distributed in CO, MD, OH. Elute may become colored due to the residual presence of heme group origination from hemoglobin present in who
| Recall number | Z-0086-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2017-10-18 |
| Classified | 2017-11-09 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2021-08-24 |
| Distributed | CO, MD, OH |
| Quantity | 911 units |
| Lot numbers | 17022802, 76675 |
| Model numbers | 200292 |
| Expiration dates | 2019-01-28 |
Product
NucliSENS Lysis Buffer Extended lot for RES 76675
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0086-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.