VITROS Chemistry Products CREA Slides, CL - Slides (Chloride), and C1 - Slides (2018-07-12)
- Starting date:
- July 12, 2018
- Posting date:
- July 27, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67312
Affected products
A. VITROS Chemistry Products CREA Slides
B. VITROS Chemistry Products CL - Slides (Chloride)
C. VITROS Chemistry Products C1 - Slides
Reason
Ortho Clinical Diagnostics (Ortho) performed internal testing and determined that the current information in the instructions for use (including listed specificity, limit of quantitation, measuring range for serum and measuring range for urine) needs to be revised.
Affected products
A. VITROS Chemistry Products CREA Slides
Lot or serial number
ALL GENERATIONS
Model or catalog number
680 2584
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS Chemistry Products CL - Slides (Chloride)
Lot or serial number
ALL GENERATIONS
Model or catalog number
844 5207
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
C. VITROS Chemistry Products C1 - Slides
Lot or serial number
ALL GENERATIONS
Model or catalog number
684 4471
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES