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U.S. Department of Health and Human Services

Class 2 Device Recall SIOOA I (EP I84) Rabbit Monoclonal Antibody

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  Class 2 Device Recall SIOOA I (EP I84) Rabbit Monoclonal Antibody see related information
Date Initiated by Firm May 10, 2016
Create Date June 17, 2016
Recall Status1 Terminated 3 on September 23, 2016
Recall Number Z-2038-2016
Recall Event ID 74179
510(K)Number K133845  
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product SIOOA I (EP I84) Rabbit Monoclonal Antibody;
Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361.
Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
Code Information Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.
Recalling Firm/
Manufacturer		 Cell Marque Corporation
6600 Sierra College Blvd
Rocklin CA 95677-4306
For Additional Information Contact R.D. Hibbert
916-746-2215
Manufacturer Reason
for Recall		 Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Product recall notifications were sent to customers on May 12, 2016. Letters advised that all unused or partially-used vials be destroyed. Customers should contact customer service for replacement and credit.
Quantity in Commerce 23 units
Distribution Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
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.
510(K) Database 510(K)s with Product Code = NJT and Original Applicant = INTUITIVE SURGICAL
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