# FDA recall Z-0086-2018

> **BioMerieux SA** · Class II · device recall initiated 2017-10-18.

## 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.

## Distribution

Distributed domestically to MD, CO, and OH.

## Key facts

- **Recall number:** Z-0086-2018
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-18
- **Report date:** 2017-11-15
- **Termination date:** 2021-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marcy L'Etoile, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2018

## Citation

> AI Analytics. FDA recall Z-0086-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0086-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*