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Piccolo Lipid Panel and Piccolo Lipid Panel Plus (2013-12-11)
- Starting date:
- December 11, 2013
- Posting date:
- January 24, 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-37663
Recalled products
- Piccolo Lipid Panel
- Piccolo Lipid Panel Plus
Reason
Fluidics flow within the disc was significantly below optimal, causing a higher than normal error rate.
Affected products
A. Piccolo Lipid Panel
Lot or serial number
- 3444AA2
Model or catalog number
- 400-0025
Companies
- Manufacturer
-
Abaxis Inc.
3240 Whipple Road
Union City
94587
California
UNITED STATES
B. Piccolo Lipid Panel Plus
Lot or serial number
- 3425AC2
Model or catalog number
- 400-0030
Companies
- Manufacturer
-
Abaxis Inc.
3240 Whipple Road
Union City
94587
California
UNITED STATES