Device product
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Z-1066-2018
Product summary
- Event
- Event 79292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1636 Kits
- Official record key
device-enforcement:Z-1066-2018
Official wording
Reason: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Code information: Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)
Distribution pattern: Nationally
Derived failure modes
-
Unknown
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).