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Vitros Chemisty Products HSCRP Reagent (2014-05-12)
- Starting date:
- May 12, 2014
- Posting date:
- June 5, 2014
- 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-39875
Recalled Products
Vitros Chemisty Products HSCRP Reagent
Reason
Calibrator values were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). This validation process was not complete prior to calibrator value assignment for Vitros chemistry products HSCRP reagent (Product Code 6801739), Generation (Gen) 28.
Affected products
Vitros Chemisty Products HSCRP Reagent (
Lot or serial number
1508-28-3487
Model or catalog number
6801739
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES