MagNA Pure 24 Instrument (2018-10-13)

Starting date:

October 13, 2018

Posting date:

November 30, 2018

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-68464

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  Reason
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  Affected products

Affected products

MagNA Pure 24 Instrument

Reason

There is a potential for cross-contamination when using specific protocols (HGDNA 200 version 1, HGDNA DS 200 version 1, fast HGDNA 200 version 1 and HGDNA 1000 protocols version 2) on the MagNA Pure 24 System.  A new version of the protocol set (version 1.4) is available. It includes updated versions of the HGDNA 200 (version 2.0), HGDNA ds 200 (version 2.0), fast HGDNA 200 (version 2.0) and HGDNA 1000 protocols (version 3.0).   The protocols have been updated to exclude the risk of a potential cross-contamination without affecting the purification performance of the HGDNA protocols.

Affected products