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U.S. Department of Health and Human Services

Class 2 Device Recall Optilite Analyser

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  Class 2 Device Recall Optilite Analyser see related information
Date Initiated by Firm May 13, 2015
Create Date January 13, 2017
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-1018-2017
Recall Event ID 75898
510(K)Number K110035  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Optilite Analyser, Product Code: IE700

Product Usage:
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
Code Information 864000290243  864000290832 864000290244  864000290833 864000290330  864000290834 864000290447  864000290836 864000290448  864000290837 864000290449  864000290838 864000290452  864000290844 864000290826  864000290845 864000290827  864000290846 864000290828  864000290847 864000290831  864000290850
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
Manufacturer Reason
for Recall		 Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
FDA Determined
Cause 2		 Component design/selection
Action Binding Site sent an Urgent Field Safety Notice letter dated May 13, 2015 to their customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the Eback Form that this notice has been received and the actions to be taken have been completed to technical.services@bindingsite.co.uk
Quantity in Commerce 129 units
Distribution Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
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 = JJE and Original Applicant = THERMO FISHER SCIENTIFIC OY
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