QIAsymphony SP (with Software 5.0.3) (2019-07-21)

Starting date:

July 21, 2019

Posting date:

August 2, 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-70605

Last updated: 2019-08-02

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  Reason
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  Affected products

Affected Products

QIAsymphony SP (with Software 5.0.3)

Reason

Incorrectly assigns 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and could have the potential to lead to delayed results or incorrect patient reporting.

Affected products