# FDA recall Z-1365-2020

> **BIOMERIEUX - Grenoble** · Class II · device recall initiated 2020-01-10.

## Product

NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS  Manufacturer  bioMerieux SA  376, Chemin de l'Orme  69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

## Reason for recall

Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201.  The issue is linked to drift of pH electrode dysfunction.

## Distribution

No US distribution. No Mexican consignees. International distribution to South Africa, Uruguay, Tanzania, Romania, Netherlands, Macao, Italy, India, Hong Kong, United Kingdom, France, Spain, Germany, China, Chile, Canada, Belgium, Australia, Argentina, Curacao.

## Key facts

- **Recall number:** Z-1365-2020
- **Recalling firm:** BIOMERIEUX - Grenoble
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-10
- **Report date:** 2020-03-04
- **Termination date:** 2022-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grenoble Cedex 1, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1365-2020

## Citation

> AI Analytics. FDA recall Z-1365-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1365-2020. Source: US FDA. Licensed CC0.

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