Recall Z-3051-2011
Bio-Rad Laboratories · initiated June 30, 2010
Product
"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.
Codes / lots: MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.
Reason for recall
KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-3051-2011
- Initiated
- June 30, 2010
- Posted by FDA
- August 22, 2011
- Terminated
- August 22, 2011
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- 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.
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA