Recall Z-3051-2011 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Bio-Rad Laboratories
"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.
| Date | Aug 22, 2011 (initiated Jun 30, 2010) |
| Status | Terminated |
| Reason | KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides. |
| Root cause | Employee error |
| Action | Bio-Rad Laboratories notified affected customers by phone on 6/30/2010 and followed up with a 2nd call on 7/13/2010. The call informed customers of the problem with the kit and requested they destroy the Crithidia slide packs. Bio-Rad send out replacement slide packs. For information or questions on this recall call Bio-Rad at (425) 498-1709. |
| Quantity | 224 kits were distributed; 35 of those kits were determined to contain the wrong slides. |
| Distribution | Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K813592 | QUANTAFLUOR FLUORESCENT TEST REAGENTS Kallestad Laboratories, Inc., Jan 18, 1982 |