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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 April 09, 2020
Create Date May 21, 2020
Recall Status1 Terminated 3 on August 19, 2022
Recall Number Z-2071-2020
Recall Event ID 85492
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite 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.
Code Information Analyzers running with software version 7.0 or 7.01
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information Contact The Binding Site Inc.
800-6334484
Manufacturer Reason
for Recall		 A software issue that may affect the analyzer's result accuracy.
FDA Determined
Cause 2		 Software design
Action The field safety notice has been issued from The Binding Site UK office to The Binding Site US office. The Binding Site US office will notify affected end users in the US. An e-back form will be provided to affected customers along with the FSN. The FSN requests the customer to complete, sign and return the e-back form to The Binding Site to confirm that they have received and understood the FSN.
Quantity in Commerce 36
Distribution US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.
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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