Vitros Chemistry Products System (2020-07-20)
- Starting date:
- July 20, 2020
- Posting date:
- August 14, 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-73695
Last updated:
2020-08-14
Affected Products
-
Vitros Chemistry Products System-BUBC Slides (Bilibrubin)
-
Vitros Chemistry Products System-TBIL Slides (Total Bilirubin)
-
Vitros XT Chemistry Products-TBIL ALKP Slides
Reason
There is potential for eltrombopag to interfere with specific Vitros Chemistry product slide assays (listed above). Eltrombopag causes a spectral interferent at the wavelengths that the Vitros TBIL, BUBC and XT TBIL-ALKP slide assays are measured. Eltrombopag was not previously identified as a potential interferent for these Vitros assays.
Affected products
A. Vitros Chemistry Products System-BUBC Slides (Bilibrubin)
Lot or serial number
All lots.
Model or catalog number
161 2365
838 3051
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. Vitros Chemistry Products System-TBIL Slides (Total Bilirubin)
Lot or serial number
All lots.
Model or catalog number
815 9931
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
C. Vitros XT Chemistry Products-TBIL ALKP Slides
Lot or serial number
All lots.
Model or catalog number
684 4296
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES