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U.S. Department of Health and Human Services

Class 3 Device Recall Bindazyme

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 Class 3 Device Recall Bindazymesee related information
Date Initiated by FirmMarch 27, 2003
Date PostedJune 21, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall NumberZ-0950-03
Recall Event ID 26433
510(K)NumberK983694 
Product Classification System, Test, Anticardiolipin Immunological - Product Code MID
ProductBindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
Code Information Lot 074461
FEI Number 2083566
Recalling Firm/
Manufacturer		 Binding Site Inc The
5889 Oberlin Drive 101
San Diego CA 92121
For Additional Information ContactDick Rowland
858-453-9177
Manufacturer Reason
for Recall		Risk of false positives.
FDA Determined
Cause 2		Other
ActionRecall notice was sent by fax March 27, 2003. The recall is complete.
Quantity in Commerce239
DistributionNationwide.
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 = MID
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