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VITROS Immunodiagnostic Products Intact PTH (Reagent Pack & Calibrators)
- Starting date:
- October 6, 2016
- Posting date:
- November 3, 2016
- 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-60780
Affected Products
Reason
Ortho confirmed that results obtained from VITROS Intact Parathyroid Hormone (iPTH) Reagent Packs are positively biased (i.e., falsely elevated) compared to an alternative commercially available method.
Ortho observed a positive bias of 40% for samples with iPTH concentrations
Ortho data demonstrated that this bias was consistent for all in-date lots.
Affected products
VITROS Immunodiagnostic Products Intact PTH (Reagent Pack & Calibrators)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 680 2892
- 680 2893
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics
Felindre Meadows, Pencoed, Bridgend, Great Britain
CF35 5PZ
UNITED KINGDOM
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