Bio-Rad Laboratories Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Bio-Rad Laboratories Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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".
Bio-Rad Laboratories Inc is recalling BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive due to The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026