Recall Z-1942-2010 ยท DAK Complement C1q, Antigen, Antiserum, Control
Inova Diagnostics Incorporated
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
| Date | Jun 30, 2010 (initiated Oct 28, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 700 kits |
| Distribution | Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031563 | BINDAZYME CLQ CIC EIA KIT The Binding Site, Ltd., Sep 10, 2003 |