Recall Z-0674-05 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Diasorin Inc.
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.
| Date | Apr 6, 2005 (initiated Oct 26, 2004) |
| Status | Terminated |
| Reason | Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml. |
| Root cause | Other |
| Action | Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications. |
| Quantity | 7 |
| Distribution | CT, MI, MT, UT & CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY Shield Diagnostics, Ltd., Oct 15, 1998 |