Recall Z-1044-2012 ยท GGN Plasma, Coagulation Control
Diagnostica Stago, Inc.
STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrino
| Date | Feb 16, 2012 (initiated Aug 23, 2011) |
| Status | Terminated |
| Reason | Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P. |
| Root cause | Nonconforming Material/Component |
| Action | Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnos |
| Quantity | 1259 units |
| Distribution | Worldwide Distribution and USA (Nationwide) and including Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943518 | STA SYSTEM CONTROL [N] + [P] KIT American Bioproducts Co., Mar 21, 1995 |