Recall Z-2994-2018 ยท GJS Test, Time, Prothrombin
Diagnostica Stago, Inc.
Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI 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 C
| Date | Jul 24, 2018 |
| Status | Terminated |
| Reason | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) |
| Root cause | Device Design |
| Action | 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) |
| Quantity | 5 kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922565 | NEOPLASTINE(R) CI KIT American Bioproducts Co., Dec 7, 1992 |