NUCLISENS¿ Lysis Buffer — Class II medical device recall Z-1365-2020
Terminated recall by BIOMERIEUX - Grenoble, reported 2020-03-04. Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an i
| Recall number | Z-1365-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOMERIEUX - Grenoble, Grenoble Cedex 1, N/A, France |
| Recall initiated | 2020-01-10 |
| Classified | 2020-02-26 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2022-04-14 |
| Countries outside the US | AR, AU, BE, CA, CL, CN, CW, DE, ES, FR, GB, HK, IN, IT, NL, RO, UY, ZA |
| Quantity | 1,024 |
| Lot numbers | 19040201 |
| Model numbers | 200292, 48X2ML |
| Expiration dates | 2021-02-28 |
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.
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-1365-2020. 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.