Recall Z-1365-2020 ยท PPM General Purpose Reagent
BIOMERIEUX - Grenoble
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.
| Date | Feb 11, 2020 (initiated Jan 10, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Equipment maintenance |
| Action | 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. |
| Quantity | 1024 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.