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

• 
  Reason
• 
  Affected products

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