QUALICHECK 3 (2016-03-23)

Starting date:

March 23, 2016

Posting date:

April 29, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58110

• Reason
• Affected products

Affected Products

QUALICHECK 3

Reason

Radiometer has recently become aware that supplementary inserts for some lots of S7335 (AutoCheck 3+ Level 1) distributed in connection with the release of sofware version 6.16 for the ABL800 series analyzers state an incorrect control range for PCO2 in "ABL810/820/830 SW more than V6.16" column. On the incorrect inserts both the low and high limits are offset by +1.3 mmHg for all affected lots. This also applies to the value in the barcode in the insert. The bar code is used to upload the values to the analyzer.

Affected products