FDAAugust 16, 2016device
Pathfast D-Dimer, Reference number: PF1051-KUS
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
What to do
FDA enforcement status: Terminated
Brands named
lsi mediencelsi
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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