VITROS Chemistry Products PHYT Slides (2018-05-10)

Starting date:

May 10, 2018

Posting date:

June 6, 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-66970

• 
  Reason
• 
  Affected products

Affected products

VITROS Chemistry Products PHYT Slides

Reason

Ortho confirmed customer complaints regarding the potential for imprecise results when using specific lots of the VITROS PHYT Slides.

Ortho performed internal testing to confirm the issue using several lots of coating 0165. The results obtained were either positively or negatively biased across the VITROS PHYT Slides measuring range of 3.00-40.00 ug/ml (11.88-158.40 umol/l).

Affected products