Health product recall

MAGNA PURE 24 System (2019-07-08)

Starting date:
July 8, 2019
Posting date:
August 2, 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-70585



Last updated: 2019-08-02

Affected Products

A. MAGNA PURE 24 INSTRUMENT

B. MAGNA PURE 24 SAMPLE RACK 24 X 2ML

C. MAGNA PURE 24 SAMPLE RACK

Reason

It was observed that some Magna Pure 24 Sample Racks do not properly hold the sample tubes in place during sample processing. When a sample tube is not properly positioned (i.e. slanted) within the rack, it could lead to an instrument crash, pipette tips missing the sample tubes during sample aspiration, and possible incorrect sample volume measurements caused by early liquid level detection (ELLD) events.

Affected products

A. MAGNA PURE 24 INSTRUMENT

Lot or serial number

1016

1113

1126

1169

1192

1232

1283

Model or catalog number

7290519001

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

New Jersey

UNITED STATES


B. MAGNA PURE 24 SAMPLE RACK 24 X 2ML

Lot or serial number

859381

860317

860472

860971

86176400

Model or catalog number

7931123001

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

New Jersey

UNITED STATES


C. MAGNA PURE 24 SAMPLE RACK

Lot or serial number

858452

860320

Model or catalog number

7930852001

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

New Jersey

UNITED STATES