VITROS Chemistry Products Na+ Slides (2019-01-20)

Starting date:
January 20, 2019
Posting date:
February 8, 2019
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-68992

Affected Products

VITROS Chemistry Products Na+ Slides

Reason

Ortho Clinical Diagnostics (Ortho) identified the potential for imprecise results when using VITROS Chemistry Products Na+ Slides, Lot 4221-0998-3223 (Product Code 8379034). The issue may be detectable by processing quality control fluids however, because the imprecision issue is intermittent, the issue is not always detectable by processing control fluids.

Affected products

VITROS Chemistry Products Na+ Slides

Lot or serial number
  • 4221-0998-3223
Model or catalog number
  • 837 9034
Companies
Manufacturer
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester, New York
14626
UNITED STATES