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