Piccolo Xpress System - Comprehensive Metabolic Panel (2019-01-30)
- Starting date:
- January 30, 2019
- Posting date:
- June 7, 2019
- 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-70117
Last updated: 2019-06-07
Affected Products
Piccolo Xpress System - Comprehensive Metabolic Panel
Reason
Abaxis is conducting a recall for specific lot numbers of the Piccolo Comprehensive Metabolic Panel Disks. Complaints were received from a small subset of customers experiencing values for the sodium assay running on average approximately 5 mmol/L higher than their reference method.
Affected products
Piccolo Xpress System - Comprehensive Metabolic Panel
Lot or serial number
8294AB4
8313AC1
8314AC1
8323AC0
8443AC1
Model or catalog number
400-0028
Companies
- Manufacturer
-
Abaxis Inc.
3240 Whipple Road
Union City
94587
California
UNITED STATES