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