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U.S. Department of Health and Human Services

Class 2 Device Recall Mouse AntiTTF1 2nd Gen Predilute

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  Class 2 Device Recall Mouse AntiTTF1 2nd Gen Predilute see related information
Date Initiated by Firm April 06, 2004
Date Posted October 09, 2004
Recall Status1 Terminated 3 on October 29, 2004
Recall Number Z-0015-05
Recall Event ID 29984
Product Classification Immunohistochemistry Assay, Antibody, Progesterone Receptor - Product Code MXZ
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.
Code Information Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205
Recalling Firm/
Manufacturer		 Zymed Laboratories Inc.
561 Eccles Ave
South San Francisco CA 94080-1906
For Additional Information Contact G.M. Butcher
650-844-4246
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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