Cobas IT Middleware (2019-07-26)

Starting date:

July 26, 2019

Posting date:

August 16, 2019

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-70735

Last updated: 2019-08-16

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  Reason
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  Affected products

Affected Products

Cobas IT Middleware

Reason

A situation was identified describing a potential situation for the cobas IT Middleware (cat # 06498027001 and 06498035001, SW versions 1.09.00, 1.09.01 And 1.10.00) To have patient results that could be sent without QC validation in very specific conditions.

Affected products