Recall Z-0612-2011 ยท LKJ Antinuclear Antibody, Antigen, Control
Bio-Rad Laboratories Inc
Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
| Date | Dec 13, 2010 (initiated Jun 24, 2010) |
| Status | Terminated |
| Reason | Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass.. |
| Root cause | Labeling mix-ups |
| Action | Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114. |
| Quantity | 37 units |
| Distribution | Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US. |
| 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 |