Health product recall

VITROS BLACK REFERENCE SLIDES (2021-04-01)

Starting date:
April 1, 2021
Posting date:
April 14, 2021
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-75385

Last updated: 2021-04-14

Affected Products 

VITROS BLACK REFERENCE SLIDES

Reason

Ortho Clinical Diagnostics initiated this recall to inform customers that some sales units of two lots of the VITROS Black Reference Slides have the incorrect part number on the box. The correct part number should be J02316. The impacted boxes are labeled J02315, which is the part number for VITROS White Reference Slides. This may have led to facilities receiving VITROS Blakc Reference Slides in place of VITROS White Reference Slides.

Affected products

VITROS BLACK REFERENCE SLIDES

Lot or serial number

9252-0058-3361
9252-0058-3362

Model or catalog number

J02316

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