Health product recall

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

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

MagNA Pure 24 Instrument

Lot or serial number

Serial no. 1016
Serial no. 1113
Serial no. 1126
Serial no. 1169
Serial no. 1192
Serial no. 1232

Model or catalog number

07290519001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY