Recall Z-1080-04 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Diagnostica Stago, Inc.
FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) an
| Date | Jul 20, 2004 (initiated Dec 4, 2002) |
| Status | Terminated |
| Reason | The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs. |
| Root cause | Other |
| Action | Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers. |
| Quantity | 965 |
| Distribution | The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.