Reported Nov 30, 2016 · Terminated
Pathfast D-Dimer, Reference number: PF1051-KUS
Lsi Medience Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lsi Medience Corporation · 13-4 Uchikanda 1 Chome · Tokyo, N/A · N/A
Is this the product you have?
- Pathfast D-Dimer
- Reference numberPF1051-KUS
- Lot codes and dates
- Lot T528
- Amount recalled
- 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Where it was sold
Why it was recalled
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
This product could cause temporary or reversible health problems — stop using it.
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