Z-1145-2010

BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control...

Name: Z-1145-2010 BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control...
Creator: Bio-Rad Laboratories Inc
Published: 2009-07-14
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2009-07-14 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of 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... on 2009-07-14. The reason FDA records is "The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1145-2010
Status: Terminated
Initiated: 2009-07-14
Posted: 2010-03-16
Terminated: 2011-03-18
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: DHC System, Test, Systemic Lupus Erythematosus
Reason for recall: The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 213 kits
Distribution: Worldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad.
Product codes and lots: 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".

Product code DHC

K032868Class IIReaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139Corgenix, Inc. / cleared 2003-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)