Device product
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Z-1068-2018
Product summary
- Event
- Event 79292
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1068-2018
Official wording
Reason: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Code information: Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)
Distribution pattern: Nationally
Derived failure modes
-
Unknown
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).