Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
FDA device recall Z-1942-2010 · posted 2010-06-30 · Terminated
Recall details
- Recalling firm
- Inova Diagnostics Incorporated
- 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".
- Action taken
- 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
- Status
- Terminated
- Product code
- DAK
- Quantity affected
- 700 kits
- Distribution
- Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.
- Date initiated
- 2009-10-28
- Date posted
- 2010-06-30
- Date terminated
- 2010-06-30
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BINDAZYME CLQ CIC EIA KIT (K031563) | The Binding Site, Ltd. | 2003-09-10 |