VITROS Chemistry Products Amyl Slides (2020-05-15)

Starting date:

May 15, 2020

Posting date:

June 12, 2020

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-73305

Last updated: 2020-06-12

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  Reason
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  Affected products

Affected Products

VITROS Chemistry Products Amyl Slides

Reason

Ortho has observed an increase in complaints, and confirmed the imprecision observed, for quality control and patient samples when using vitros amyl slides. Some laboratory's quality control fluid record statistics have shown SDS that are larger than the estimated within-lab SD on the VITROS performance verifier control assay sheets. Complaints have also been received regarding VITROS Amyl Slides QC data exceeding within-lab SD when using other manufacturers' controls.

Affected products