Recall Z-0672-05 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
Diasorin Inc.
Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
| Date | Apr 6, 2005 (initiated Apr 20, 2004) |
| Status | Terminated |
| Reason | An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing. |
| Root cause | Other |
| Action | Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin. |
| Quantity | 29 |
| Distribution | CT, FL, NY, WA, TX, AR, TN, CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT Shield Diagnostics, Ltd., Nov 21, 1994 |