Health product recall

Chemstrip 10A and Urisys 1100 Analyzer (2018-05-10)

Starting date:
May 10, 2018
Posting date:
June 14, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67042

Affected products

A. Chemstrip 10A

B. Urisys 1100 Analyzer

Reason

It was discovered during internal performance studies that the Limit Of Detection (LOD) of the Chemstrip 10A needs to be changed since the current performance claim showed deviating values for protein, nitrite, ketone bodies, leukocytes, blood (intact erythrocytes) when measured on Urisys 1100 analyzer.

Affected products

A. Chemstrip 10A

Lot or serial number

All lots.

Model or catalog number

11379208119

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


B. Urisys 1100 Analyzer

Lot or serial number

All lots.

Model or catalog number

03617548001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY