Z-2071-2020 Class II Terminated
FDA device recall Z-2071-2020 was initiated by The Binding Site Group, Ltd. on April 9, 2020 and is designated Class II. Reason for recall: A software issue that may affect the analyzer's result accuracy. The recall status is terminated (terminated August 19, 2022). Affected quantity: 36.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 9, 2020
- Termination Date
- August 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36
Product Description
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.
Reason for Recall
A software issue that may affect the analyzer's result accuracy.
Distribution Pattern
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.
Code Information
Analyzers running with software version 7.0 or 7.01