cobas IT middleware (2019-06-12)

Starting date:

June 12, 2019

Posting date:

June 28, 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-70325

Last updated: 2019-06-28

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  Reason
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  Affected products

Affected Products

cobas IT middleware

Reason

The cobas IT middleware of software version 1.10.00 using the multi-level QC configuration may allow patient results to be released with invalid QC results. This affect the evaluation of the QC lock-status (QC error) when more than one level is configured to be used.

Affected products