Pathfast D-Dimer recall
Pathfast D-Dimer, Reference number: PF1051-KUS
Why was Pathfast D-Dimer recalled?
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot T528
- Product
- Pathfast D-Dimer, Reference number: PF1051-KUS
- Recalling firm
- Lsi Medience Corporation
- 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.
- Recall date
- November 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)