The Binding Site Group, Ltd. recalls The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Cl…
- Recall date
- April 9, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2071-2020
- FDA classification
- Class II
- Brand / firm
- The Binding Site Group, Ltd.
- Sold / distributed
- 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.
Why it was recalled
A software issue that may affect the analyzer's result accuracy.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever The Binding Site Group, Ltd. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: The Binding Site Group, Ltd.