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
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
VITROS Chemistry Products Amyl Slides
Lot or serial number
All lots.
Model or catalog number
178080
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES