[Recalled] Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. — The barcode for the ABL77 on the insert incorrectly enters a control range for… | FDA 2006-

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.

This Class III 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

• ABL800 analyzer, model numbers 393-800 and 393-801. — Class II
• ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. — Class II
• Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. — Class II
• TCM CombiM Modules 903-111 — Class II
• Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring — Class II
• 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

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.