Health product recall

VITROS Chemistry Products Calibrator Kit 2 (2019-12-17)

Starting date:
December 17, 2019
Posting date:
January 24, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72171



Last updated: 2020-01-24

Affected Products

VITROS Chemistry Products Calibrator Kit 2

Reason

Negatively biased URINE results may occur when using specific coatings of VITROS Chemistry Products Na+ Slides with VITROS Chemistry Products Calibrator Kit 2.

Affected products

VITROS Chemistry Products Calibrator Kit 2

Lot or serial number
  • 219
  • 277
  • 288
  • 298
Model or catalog number

166 2659

Companies
Manufacturer

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive

Rochester

14626

New York

UNITED STATES