FDA Medical Device Recalls (openFDA)
Zymed Laboratories Inc.: 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.
- Recall number
- Z-0015-05
- Recalling firm
- Zymed Laboratories Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2004-04-06
- Posted
- 2004-10-09
- Terminated
- 2004-10-29
- Reason
- Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
- Root cause
- Other
- Action
- 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.
- Quantity
- 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 distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.
- Lot, serial or model codes
- Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MXZ
- Firm FEI
- 3000203719
- Firm city
- South San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28