Recall Z-1426-2010 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
American Diagnostica, Inc.
REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.
| Date | Apr 21, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators |
| Root cause | Process control |
| Action | Three emails "REF 822 lot 102401 needs to be recalled" dated March 1, 2010 was sent to three customers. The emails described the product, problem and action to be taken by the customers. The customers should send the kit to the firm (SEKISUI american diagnostica inc.) attention of Leigh Ayres, Director, Regulatoy Affairs and Quality Assurance. If you have any question, please call 1-203-602-7777. |
| Quantity | 25 kits |
| Distribution | Worldwide distribution: USA and UK, Taiwan and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 American Diagnostica, Inc., Mar 7, 2002 |