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VITROS Chemistry Products VANC Reagent
- Starting date:
- February 22, 2017
- Posting date:
- March 16, 2017
- 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-62642
Reason
Ortho Clinical Diagnostics (Ortho) initiated a recall due to the potential for biased results generated using three lots of Vitros VANC (vancomycin) Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
Affected products
VITROS Chemistry Products VANC Reagent
Lot or serial number
31-5407
31-5474
31-5506
Model or catalog number
6801709
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES