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Architect I system - Intact PTH Reagent Assay (2014-02-13)
- Starting date:
- February 13, 2014
- 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-38489
Recalled Products
Architect I system - Intact PTH Reagent Assay
Reason
A performance shift was observed in the architect intact PTH assay that has the potential to generate falsely elevated results on patient samples. Results generated in a study using current in-date reagent and calibrator lots, demonstrated a magnitude of shift relative averaging approximately 13 to 45 percent when compared to package insert data. The shift was observed across the full analytical range of the assay.
Affected products
Architect I system - Intact PTH Reagent Assay
Lot or serial number
- 8K25-01
- 8K25-10
- 8K25-20
- 8K25-25
Model or catalog number
All lots
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY