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[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 th

recall fda device united-kingdom

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductThe 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.
Brand / manufacturerThe Binding Site Group, Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2071-2020
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date09 April 2020
EAN / barcode05051700017176

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: A software issue that may affect the analyzer's result accuracy.

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from The Binding Site Group, Ltd.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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