Cobas Pro ISE Analytical Unit (2019-07-29)

Starting date:

July 29, 2019

Posting date:

August 23, 2019

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-70773

Last updated: 2019-08-23

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  Reason
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  Affected products

Affected Products

Cobas Pro ISE Analytical Unit

Reason

The manufacturer Hitachi High Technologies advised us about a quality issue with the high pressure solenoid valves produced between January 2019 and May 2019 that could lead to erroneous results without data flag or system alarm. In Canada, no customers are impacted since only one potentially affected instrument was imported, but was not distributed to any customers. The manufacturer advised us about this issue on 12-Jul-2019.

Affected products