Health product recall

Cobas Integra Fructosamine (2019-11-11)

Starting date:
November 11, 2019
Posting date:
November 22, 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-71678

Last updated: 2019-11-22

Affected Products

Cobas Integra Fructosamine

Reason

During internal reagent testing it was shown that the linearity claim of the 1000umol/ml for the cobas Integra Fructosamine used on cobas Integra 400 Plus Analyzer could not be achieved anymore. As a consequence, the manufacturer reduced the upper measuring range to 900umol/l. The manufacturer advised us of this issue on 2019/10/28.

Affected products

Cobas Integra Fructosamine

Lot or serial number

All lots.

Model or catalog number

194467

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY