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BRT VERIFICATION SAMPLES (2016-02-12)
- Starting date:
- February 12, 2016
- Posting date:
- March 10, 2016
- 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-57456
Affected Products
- A. BRT VERIFICATION SAMPLES
Reason
Complaints were received from customers who observed values for some chemistry analytes below the manufacturer's target. The above results in the inability to verify the analyte(s) linearity across the reportable range during the validation process of the Piccolo Xpress blood chemistry analyzer.
Affected products
-
A. BRT VERIFICATION SAMPLES
Lot or serial number
- 1501038
Model or catalog number
- 100-9011
Companies
- Manufacturer
-
BIORESOURCE TECHNOLOGY INC
1800 NORTH COMMERCE PARKWAY, SUITE 1,
WESTON
Florida
UNITED STATES