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

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  Reason
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  Affected products

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