[Recalled] ABL800 analyzer, model numbers 393-800 and 393-801. — The analyzer software may cause a mis-match of patient demographics and test re… | FDA 2018-07-03

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

This Class II recall concerns device products distributed in United States 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 Radiometer America Inc

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• HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packa — Class II
• ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. — Class II

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.