Pathfast D-Dimer — Class II medical device recall Z-0646-2017
Terminated recall by Lsi Medience Corporation, reported 2016-11-30, distributed in AL, FL, ID, MA. Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the pro
| Recall number | Z-0646-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lsi Medience Corporation, Tokyo, N/A, Japan |
| Recall initiated | 2016-08-16 |
| Classified | 2016-11-21 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-02-27 |
| Distributed | AL, FL, ID, MA |
| Lot numbers | T528 |
Product
Pathfast D-Dimer, Reference number: PF1051-KUS
Reason for recall
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0646-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.