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U.S. Department of Health and Human Services

Class 3 Device Recall AntiCardiolipin IgM ELISA Test Kit

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 Class 3 Device Recall AntiCardiolipin IgM ELISA Test Kitsee related information
Date Initiated by FirmJuly 14, 2009
Date PostedMarch 16, 2010
Recall Status1 Terminated 3 on March 18, 2011
Recall NumberZ-1145-2010
Recall Event ID 52889
510(K)NumberK032868 
Product Classification in vitro diagnostic - Product Code DHC
ProductBIO-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.
Code Information 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".
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
510-724-7000
Manufacturer Reason
for Recall		The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBio-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 Commerce213 kits
DistributionWorldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DHC
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