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U.S. Department of Health and Human Services

Class 2 Device Recall Estrogen Receptor AB11 (Clone ID5)

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  Class 2 Device Recall Estrogen Receptor AB11 (Clone ID5) see related information
Date Initiated by Firm December 06, 2013
Date Posted January 16, 2014
Recall Status1 Terminated 3 on February 25, 2014
Recall Number Z-0775-2014
Recall Event ID 67065
Product Classification Reagents,specific,analyte - Product Code MVU
Product Estrogen Receptor AB-11 (Clone ID5)
Mouse Monoclonal Antibody
1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA

Thermo Fisher Scientific
Anatomical Pathology
Tudor Rd., Manor Park
Rancorn, Cheshire WA7 1TA UK


Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Code Information PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
Recalling Firm/
Manufacturer		 Lab Vision Corporation
46117 Landing Pkwy
Fremont CA 94538-6407
For Additional Information Contact John Green
510-979-5000
Manufacturer Reason
for Recall		 Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
FDA Determined
Cause 2		 Under Investigation by firm
Action Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.
Quantity in Commerce 5
Distribution Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
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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