Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.
This recall has been terminated (originally issued October 9, 2004).
- Company
- Zymed Laboratories Inc.
- Recall Initiated
- April 6, 2004
- Posted
- October 9, 2004
- Terminated
- October 29, 2004
- Recall Number
- Z-0015-05
- Quantity
- 24 vials of the mouse anti-TTF-1 concentrate have been released in distribution.
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
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.
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 distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.
Lot / Code Info
Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205
Root Cause
Other
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.