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U.S. Department of Health and Human Services

Class 3 Device Recall Optilite IgG4 Kit

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  Class 3 Device Recall Optilite IgG4 Kit see related information
Date Initiated by Firm December 23, 2016
Create Date July 27, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1089-2017
Recall Event ID 76131
510(K)Number K150526  
Product Classification Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Product Optilite IgG4 Kit
Product Code: LK009.OPT.A
Code Information Lot #401413
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information Contact Germaine Schwider
858-4539177
Manufacturer Reason
for Recall		 A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
FDA Determined
Cause 2		 Under Investigation by firm
Action Customer notification letters were sent on 12/23/16. The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification. The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred. Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator. If you have any questions contact Technical Services.
Quantity in Commerce 9 users
Distribution U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
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 = CFN and Original Applicant = THE BINDING SITE GROUP LTD
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