Recall Z-0540-2011 ยท LKJ Antinuclear Antibody, Antigen, Control
Bio-Rad Laboratories Inc
Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.
| Date | Dec 6, 2010 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
| Root cause | Other |
| Action | Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall. |
| Distribution | Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK. |
| 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 |