Stat Profile Prime CCS Comp Analyzer (2017-06-09)
- Starting date:
- June 9, 2017
- Posting date:
- July 27, 2018
- 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-67314
Affected products
Stat Profile Prime CCS Comp Analyzer
Reason
When a patient result is in a pending state, a scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test result.
Affected products
Stat Profile Prime CCS Comp Analyzer
Lot or serial number
P07115190
P07115390
P07414070
P0751321P
P07514330
P07514400
Model or catalog number
52857
Companies
- Manufacturer
-
Nova Biomedical Corporation
200 Prospect St
Waltham
02454
Massachusetts
UNITED STATES