Health product recall

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