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U.S. Department of Health and Human Services

Class 2 Device Recall UltraVision Detection System, AntiRabbit, AlkPhos/BCIP/NBT (Ready to Use)

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  Class 2 Device Recall UltraVision Detection System, AntiRabbit, AlkPhos/BCIP/NBT (Ready to Use) see related information
Date Initiated by Firm January 11, 2012
Date Posted February 22, 2012
Recall Status1 Terminated 3 on July 20, 2012
Recall Number Z-1088-2012
Recall Event ID 60967
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product UltraVision Detection System;
Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538

Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
Code Information Catalog number: TR-015-AB; Lot Number: RAB110810, Exp. 10/2012.  
Recalling Firm/
Manufacturer		 Lab Vision Corporation
46360 Fremont Blvd
Fremont CA 94538-6406
For Additional Information Contact Karen Lee
510-979-5000 Ext. 31814
Manufacturer Reason
for Recall		 Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.
Quantity in Commerce 31 kits in total
Distribution Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
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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