Health product recall

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

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

VITROS Chemistry Products Na+ Slides

Lot or serial number

Lots From Gen:8,13,14,16,17,18

Model or catalog number

8379034

Companies
Manufacturer
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES