FDA Medical Device Recalls (openFDA)
Lsi Medience Corporation: Pathfast D-Dimer, Reference number: PF1051-KUS
- Recall number
- Z-0646-2017
- Recalling firm
- Lsi Medience Corporation
- Product
- Pathfast D-Dimer, Reference number: PF1051-KUS
- Status
- Terminated
- Initiated
- 2016-08-16
- Posted
- 2016-11-21
- Terminated
- 2017-02-27
- 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.
- Lot, serial or model codes
- Lot T528
- 510(k) numbers
- ["K072288"]
- PMA numbers
- not on file
- Product code
- GHH
- Firm FEI
- 3010736318
- Firm city
- Tokyo
- Firm state
- 1 Chome
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28