Recall Z-1365-2020— BIOMERIEUX - Grenoble
Class II · Terminated
Class II FDA medical device recall by BIOMERIEUX - Grenoble, initiated 2020-01-10, terminated 2022-04-14. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- BIOMERIEUX - Grenoble
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-10
- Terminated
- 2022-04-14
- Firm location
- Grenoble Cedex 1, N/A, France
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.