Recall Z-0613-2011 ยท LKJ Antinuclear Antibody, Antigen, Control
Bio-Rad Laboratories Inc
Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.
| Date | Dec 13, 2010 (initiated Feb 24, 2010) |
| Status | Terminated |
| Reason | False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment . |
| Root cause | Other |
| Action | Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form. Bio-Rad can be contacted at 510 724-7000 concerning this recall. |
| Distribution | Nationwide Distribution: to Meridian Diagnostics in Ohio. |
| 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 |