Recall Z-1479-2011 ยท LKJ Antinuclear Antibody, Antigen, Control
Bio-Rad Laboratories Inc
Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
| Date | Mar 2, 2011 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be av |
| Quantity | 2,109 bulk packs |
| Distribution | Nationwide Distribution -- New York, 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 |