BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- July 14, 2009
- Posted
- March 16, 2010
- Terminated
- March 18, 2011
- Recall Number
- Z-1145-2010
- Quantity
- 213 kits
- Firm Location
- Hercules, CA
Reason for Recall
The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.
Distribution
Worldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad.
Lot / Code Info
Kit identified on label as "REF 425-2020" and "LOT CL-863". Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591".
Root Cause
Nonconforming Material/Component
Action Taken
Bio-Rad initiated its field correction on July 14, 2009. The firm notified domestic consignees by phone followed by fax, and each subsidiary will be given an urgent notice, subsidiary response form, customer medical device correction notification, acknowledgement form and a listing of consignees. The subsidiaries must contact customers as instructed.