"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.
This recall has been terminated (originally issued August 22, 2011).
- Company
- Bio-Rad Laboratories
- Recall Initiated
- June 30, 2010
- Posted
- August 22, 2011
- Terminated
- August 22, 2011
- Recall Number
- Z-3051-2011
- Quantity
- 224 kits were distributed; 35 of those kits were determined to contain the wrong slides.
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
Distribution
Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.
Lot / Code Info
MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.
Root 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.