Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
FDA Recall Z-0950-03 · Posted 2003-06-21
Recalling FirmBinding Site Inc The
Recall StatusTerminated
Product CodeMID
Date Initiated2003-03-27
Date Terminated2004-12-01
Product Quantity239
Reason for Recall
Risk of false positives.
Firm Action
Recall notice was sent by fax March 27, 2003. The recall is complete.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.