Recall Z-2994-2018
Diagnostica Stago, Inc. · initiated July 24, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 Code 4922; CDC Test System Codes 4677 and 4875).
Codes / lots: Lot Number/Exp. Date/UDI 251426 2018-11-30 (01)03607450006667(11)161130(17)181130(10)251426(241)00666; 251763 2019-02-28 (01)03607450006667(11)170228(17)190228(10)251763(241)00666
Reason for recall
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
FDA-determined cause: Device Design
Action taken
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)
Details
- Recall number
- Z-2994-2018
- Initiated
- July 24, 2018
- Terminated
- May 18, 2020
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 5 kits
- Distribution
- Nationwide
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2993-2018 Class II | Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for…QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) | 07/24/2018Terminated |