Food, drugs, devices › BioMerieux SA
Device recall: NucliSENS Lysis Buffer Extended lot for RES 76675
BioMerieux SA (Marcy L'Etoile, N/A) initiated this device recall on 18 Oct 2017; FDA lists 1 product record under event 78387, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 24 Aug 2021. Initiation: voluntary: firm initiated. BioMerieux SA has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
BioMerieux SA, Marcy L'Etoile, N/A, France.
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…"
Distribution
"Distributed domestically to MD, CO, and OH."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0086-2018 | NucliSENS Lysis Buffer Extended lot for RES 76675 | 911 units | Class II | Terminated | 15 Nov 2017 |
Context
Other enforcement events for BioMerieux SA
All 21 events for BioMerieux SA
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed domestically to MD, CO, and OH."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Aug 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.