Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
Recall
- Recall Number
- Z-2993-2018
- Event Number
- 80826
- Firm
- Diagnostica Stago, Inc.
- FEI Number
- 2245451
- Product Code
- GJS
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 24, 2018
- Terminated
- May 18, 2020
- Address
- 5 Century Dr, Parsippany, NJ, 07054-4607
Description
Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Diagnostica Stago issued notification on July 24, 2018 to US Customers provided the reason for the notification, actions to be taken to mitigate the risk. Action: If you have in your laboratory, any of the lots among those listed in the appendix, we are asking you to: If it is not already done, run a Quality Control test at every change of vial. Return to your Stago affiliate, by fax or e-mail, the enclosed form completed and confirming that you have read this letter. Questions contact Stago Hotline (1-800-725-0607)
Nationwide
24043 kits