Z-1942-2010

Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021

Name: Z-1942-2010 Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
Creator: Inova Diagnostics Incorporated
Published: 2009-10-28
License: https://open.fda.gov/license/

Inova Diagnostics, Inc. / initiated 2009-10-28 / Terminated / root cause: manufacturing process

FDA source

Inova Diagnostics Incorporated began a recall of Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021 on 2009-10-28. The reason FDA records is "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...". 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-1942-2010
Status: Terminated
Initiated: 2009-10-28
Posted: 2010-06-30
Terminated: 2010-06-30
Recalling firm: Inova Diagnostics, Inc.
Product: Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
Product code: DAK Complement C1q, Antigen, Antiserum, Control
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".
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 700 kits
Distribution: Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.
Product codes and lots: Lot numbers: 273005A, 273005B, 273005C, and 273005D

Product code DAK

K031563Class IIBindazyme Clq Cic Eia KitThe Binding Site, Ltd. / cleared 2003-09-10

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)