FDAFDA · Food and drugs·Recall number Z-2071-2020
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.
Published May 27, 2020 · Recall initiated: April 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software issue that may affect the analyzer's result accuracy.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- 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.
- Lot
- Analyzers running with software version 7.0 or 7.01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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