Recall Z-1388-05 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Beckman Coulter Inc
Access Immunoassay Systems Assay Protocol: Dil-AFP.
| Date | Aug 23, 2005 (initiated Jul 18, 2005) |
| Status | Terminated |
| Reason | Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results. |
| Root cause | Other |
| Action | Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions. |
| Quantity | 311 USA 16 Canada |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 Beckman Instruments, Inc., May 1, 1998 |