AQUIOS CL Flow Cytometer System (2018-01-29)

Starting date:

January 29, 2018

Posting date:

March 2, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66080

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  Reason
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  Affected products

Affected products

AQUIOS CL Flow Cytometer System

Reason

If the following sequence of events is followed, it will result in sample misidentification and erroneous results will be generated. The system will not identify or flag the erroneous results.

• The stat button is selected within AQUIOS CL Software and the user opens the single-tube loader door.
• User creates a test request when prompted, places a specimen tube in single tube loader, and closes the single-tube loader door.
• the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the "details" column on running screen changes to "prepping" for that sample.
• User removes the first specimen tube and replaces with a different specimen tube.
• If another request is entered for the new specimen and the single-tube loader door is closed, the new specimen tube will be prepared twice. Both test requests will be processed with 2nd specimen tube.
• If another request is not entered for new specimen and the single-tube loader door is closed, the new specimen tube will be prepared once. The first test request will be processed with 2nd specimen tube.

Affected products