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Terminated

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.

FDA Recall Z-0015-05 · Posted 2004-10-09

Recalling FirmZymed Laboratories Inc.
Recall StatusTerminated
Product CodeMXZ
Date Initiated2004-04-06
Date Terminated2004-10-29
Product Quantity24 vials of the mouse anti-TTF-1 concentrate have been released in distribution.

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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