Pathfast D-Dimer, Reference number: PF1051-KUS
FDA device recall Z-0646-2017 · posted 2016-11-21 · Terminated
Recall details
- Recalling firm
- Lsi Medience Corporation
- Reason for recall
- Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GHH
- Quantity affected
- 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.
- Date initiated
- 2016-08-16
- Date posted
- 2016-11-21
- Date terminated
- 2017-02-27
- Location
- Tokyo, 1 Chome, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATHFAST D-DIMER (K072288) | Mitsubishi Kagaku Iatron | 2009-05-06 |