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VITROS Chemistry Products Li Slides
- Starting date:
- February 2, 2017
- Posting date:
- February 28, 2017
- 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-62402
Reason
Ortho Clinical Diagnostics (Ortho) identified the potential for intermittent imprecision in results generated using affected lots of Vitros Li slides. When present, the potential imprecision does not affect random slides, but rather sequential slides within or across slide cartridges caused by a short-duration imperfection during manufacturing.
Affected products
VITROS Chemistry Products Li Slides
Lot or serial number
- 3124-0108-6568
- 3124-0108-6569
Model or catalog number
- 1632660
- 8318925
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES