BIOMERIEUX Grenoble Biomerieux Institut Christophe Merieux; 5 Rue Des Berges; Cs 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
BIOMERIEUX Grenoble Biomerieux Institut Christophe Merieux; 5 Rue Des Berges; Cs
Lot Codes / Batch Numbers
Lot 19040201, Expiry 28-Feb-2021
Products Sold
Lot 19040201, Expiry 28-Feb-2021
BIOMERIEUX Grenoble Biomerieux Institut Christophe Merieux; 5 Rue Des Berges; Cs is recalling NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l' due to Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 2. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees notified via FedEx Express 2 day delivery service with recall letter dated 10 January 2020. The letter identified affected product, stated reason for recall, and requested product to not be used for testing of whole blood samples containing blood and other specimens containing blood. Samples with no hemoglobin are not impacted by the issue and can be used with expected performance. A Recall Acknowledgement Form was requested to be completed and returned via fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026