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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zymed Laboratories Inc.
Lot Codes / Batch Numbers
Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205
Products Sold
Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205
Zymed Laboratories Inc. is recalling Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types due to Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, IL, MD, NY, OH, TX, DC
Page updated: Jan 10, 2026