Recall Z-1108-2008 ยท MMI Immunoassay Method, Troponin Subunit
Beckman Coulter Inc
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
| Date | Mar 19, 2008 (initiated Jul 19, 2007) |
| Status | Terminated |
| Reason | Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. |
| Root cause | Process design |
| Action | A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Access lmmunoassay System Reaction Vessels lot 1201291 and 1201431. The customers were informed that a small percentage of the reaction vessels (Lot #s: 1201291and 1201431 ) have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. The customers were instructed to discontinue use and discard these lots. A response form was included. |
| Quantity | 264 units in the US; 9 units in Canada |
| Distribution | Nationwide & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |