Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used
FDA device recall Z-0015-05 · posted 2004-10-09 · Terminated
Recall details
- Recalling firm
- Zymed Laboratories Inc.
- Reason for recall
- Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
- Action taken
- The firm has conducted telephone calls and visits to its consignees, with confirmation done by phone and fax. The firm has recovered or accounted for 100% of the products, either returned or destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- MXZ
- Quantity affected
- 24 vials of the mouse anti-TTF-1 concentrate have been released in distribution.
- Distribution
- The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distribu
- Date initiated
- 2004-04-06
- Date posted
- 2004-10-09
- Date terminated
- 2004-10-29
- Location
- South San Francisco, CA
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