ABL90 FLEX - Analyzer (2018-05-07)

Starting date:

May 7, 2018

Posting date:

June 22, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67068

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  Reason
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  Affected products

Affected products

ABL90 FLEX - Analyzer

Reason

Radiometer has recently become aware that the ABL90 FLEX in a very rare specific situation can aspirate CAL 2 solution instead of rinse solution. The specific situation can occur when the following take place:

• The analyzer is in ready mode.
• Operator lifts the inlet and then closes it again, thereby initiating a rinse.
• Immediately after lifts the inlet and quickly closes it again.

This may cause incorrect measurements for the several parameters, showing a high pattern for pH, Na+, Cl− and a low pattern for pCO2, K+ and Ca2+. Some of the parameters will not have an error message or question mark indicating a problem with the result. The wrong reporting will continue until the analyzer flow selector has reset.

Important: The flow selector will reset as part of the automatic error removal process performed during repeated automatic calibrations, QC measurements or during installation of the solution pack.

Risk for the patient, the described error may potentially cause a patient with either:

• Moderate to severe Hyperkalemia
• Severe Hypoxia
• Severe Carbon Monoxide Poisoning

Affected products