Lsi Medience Corporation recalls Pathfast D-Dimer, Reference number: PF1051-KUS
- Recall date
- August 16, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0646-2017
- FDA classification
- Class II
- Brand / firm
- Lsi Medience Corporation
- Sold / distributed
- US Distribution to the states of : AL, FL, ID and MA.
Why it was recalled
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pathfast D-Dimer, Reference number: PF1051-KUS
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