Health product recall

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

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

Cobas Pro ISE Analytical Unit

Lot or serial number

1909-04-01

Model or catalog number

8468537001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY