Recall Z-0646-2017 ยท GHH Fibrin Split Products
Lsi Medience Corporation
Pathfast D-Dimer, Reference number: PF1051-KUS
| Date | Nov 21, 2016 (initiated Aug 16, 2016) |
| Status | Terminated |
| Reason | Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified by letter sent via email on/about August 1, 2016. They were instructed to stop using and destroy the affected kits. They were to perform a retrospective analysis of the patients tested on the batch and investigate further. A Destruction Certificate was attached to be completed and returned to Verbatim Americas, LLC. For further questions please call (704) 547-6517. |
| Quantity | 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges). |
| Distribution | US Distribution to the states of : AL, FL, ID and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072288 | PATHFAST D-DIMER Mitsubishi Kagaku Iatron, May 6, 2009 |