VITROS Chemistry Products Na+ Slides (2018-06-06)

Starting date:

June 6, 2018

Posting date:

June 22, 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-67088

• 
  Reason
• 
  Affected products

Affected products

VITROS Chemistry Products Na+ Slides

Reason

Ortho Clinical Diagnostics (Ortho) identified the potential for positively biased results to occur for serum/plasma and urine samples when using the affected VITROS Na+ Slides. The results may be positively biased and quality control fluids may be outside of the expected ranges. The amount of bias in the VITROS Na+ method is dependent upon multiple sources of variability.

Two separate issues have been identified:

• VITROS Na+ Slides, gens 8 & 13: positively biased urine sample results
• VITROS Na+ Slides gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results

Affected products