Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Recall Z-0646-2017 · Posted 2016-11-21
Recalling FirmLsi Medience Corporation
Recall StatusTerminated
Product CodeGHH
Date Initiated2016-08-16
Date Terminated2017-02-27
Product Quantity42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Reason for Recall
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Distribution to the states of : AL, FL, ID and MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.