Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
FDA Recall Z-1942-2010 · Posted 2010-06-30
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Recalling FirmInova Diagnostics Incorporated
Recall StatusTerminated
Product CodeDAK
Date Initiated2009-10-28
Date Terminated2010-06-30
Product Quantity700 kits
Reason for Recall
The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".
Firm Action
Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009.
The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.
Root Cause
Process control
Distribution Pattern
Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.
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.
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