Z-0015-05

Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of...

Name: Z-0015-05 Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of...
Creator: Zymed Laboratories Inc.
Published: 2004-04-06
License: https://open.fda.gov/license/

Zymed Laboratories Inc. / initiated 2004-04-06 / Terminated

FDA source

Zymed Laboratories Inc. began a recall of 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 on 2004-04-06. The reason FDA records is "Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0015-05
Status: Terminated
Initiated: 2004-04-06
Posted: 2004-10-09
Terminated: 2004-10-29
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.
Product code: MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
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.
FDA 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 in commerce: 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.
Product codes and lots: Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205

Product code MXZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)