FDA Device recall Z-0646-2017
Pathfast D-Dimer, Reference number: PF1051-KUS
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of Pathfast D-Dimer, Reference number: PF1051-KUS by Lsi Medience, citing two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0646-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-16 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Lsi Medience |
| Distribution | AL, FL, ID, MA |
Product
Pathfast D-Dimer, Reference number: PF1051-KUS
Reason
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Identifiers
| code_info | Lot T528 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0646-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.