Health product recall

Rapid QC Complete Solution Level 2 (2019-01-02)

Starting date:
January 2, 2019
Posting date:
January 23, 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-68894

Affected products

Rapid QC Complete Solution Level 2

Reason

Siemens healthcare diagnostics has confirmed that RapidQC complete solution, level 2, lot numbers 362801 and 362802, contain incorrect value assignments for the reported targets and ranges for both glucose and lactate. This incorrect value assignment is present for RAPIDPoint 405/500 Blood Gas Systems and RAPIDLab 1260/1265 Systems.

Affected products

Rapid QC Complete Solution Level 2

Lot or serial number
  • 362801
  • 362802
Model or catalog number

10309926

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES