Recall Z-0218-2019 ยท PPM General Purpose Reagent
BioMerieux SA
NucliSENS Magnetic Extraction Reagents
| Date | Sep 17, 2018 |
| Status | Terminated |
| Reason | Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product. |
| Root cause | Other |
| Action | bioMerieux notified customers on about 09/17/2018 via "URGENT PRODUCT REMOVAL NOTICE". Instructions included the following. 1. Confirm this information has been distributed to, and reviewed by, all appropriate personnel within your organization. Retain a copy of this letter for your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product. 2. Please discontinue use and destroy any impacted product remaining in your local inventory and contact your local bioMrieux, Inc. representative for credit. 3. A |
| Quantity | 42 units |
| Distribution | Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.