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.
Reported: May 27, 2020 Initiated: April 9, 2020 #Z-2071-2020
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.
Details
- Recalling Firm
- The Binding Site Group, Ltd.
- Units Affected
- 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.
- Location
- Birmingham, N/A
Frequently Asked Questions
What product 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.. Recalled by The Binding Site Group, Ltd.. Units affected: 36.
Why was this product recalled? ▼
A software issue that may affect the analyzer's result accuracy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2071-2020.
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