Recall Z-1478-2011 ยท LKJ Antinuclear Antibody, Antigen, Control
Bio-Rad Laboratories Inc
DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
| Date | Mar 2, 2011 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. |
| Root cause | Nonconforming Material/Component |
| Action | Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws. |
| Quantity | 999 kits |
| Distribution | Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT Helix Diagnostics, Inc., Dec 15, 1995 |