Recall Z-0738-2020 ยท GGN Plasma, Coagulation Control
Diagnostica Stago, Inc.
STA SYSTEM CONROL N + P (ref. 00678)
| Date | Dec 23, 2019 (initiated Nov 18, 2019) |
| Status | Terminated |
| Reason | A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results. |
| Root cause | Process control |
| Action | On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: FIELD SAFETY NOTICE Combined use of the following reagents STA UNICALIBRATOR (ref. 00675) and STA DEFICIENT VIII (ref. 00725) STA DEFICIENT IX (ref. 00724) Dear Customer, You are using the STA Unicalibrator (00675) and STA Deficient VIII (00725) and/or STA Deficient IX (00724) and according to our records, you have ordered and received in your laboratory one or several kits of the STA - Unicalibrator listed in Appendix 1. Following the identification of a defect, please s |
| Quantity | 5,437 |
| Distribution | US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK |
| 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 |