Recall Z-1713-2017 ยท PPM General Purpose Reagent
BioMerieux SA
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
| Date | Mar 19, 2017 (initiated Mar 7, 2017) |
| Status | Terminated |
| Reason | Problem with colored eluates for whole blood extractions |
| Root cause | Under Investigation by firm |
| Action | BioMerieux sent an Urgent Product Safety Correction Notice to all affected customers electronically on March 7, 2017. US customers will be sent a separate letter. The letter requested that they discard the product and notify all customers that use the product. The notification included a reply form to be returned. Customers with questions were instructed to contact their local bioMerieux Customer Service representative. For questions regarding this recall call 314-731-7301. |
| Quantity | 1025 |
| Distribution | Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.