RAPIDPoint 405, 500 and RAPIDLab 1245 Blood Gas Analyzer (2018-07-24)
- Starting date:
- July 24, 2018
- Posting date:
- August 17, 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-67392
Affected products
- RAPIDPoint 405 Blood Gas Analyzer
- RAPIDLab 1245 Blood Gas Analyzer
- RAPIDPoint 500 Blood Gas Analyzer
Reason
Siemens Healthcare Diagnostics has determined that 1 mg/ml and 2 mg/ml of hydroxocobalamin may interfere with Total hemoglobin (tHb) and some of the co-ox fractions that are reported on the RAPIDPoint 405, RAPIDPoint 500, RAPIDLab1245 and RAPIDLab1265 blood gas analyzers.
There have not been any reports of injury due to this issue. Siemens is issuing an Urgent Field Safety Notice (UFSN) to inform customers of this potential interfering substance.
Affected products
A. RAPIDPoint 405 Blood Gas Analyzer
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- 05320281
- 129887
- RAPIDPOINT 405
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. RAPIDLab 1245 Blood Gas Analyzer
Lot or serial number
10321844
10337179
10491395
Model or catalog number
1245
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
C. RAPIDPoint 500 Blood Gas Analyzer
Lot or serial number
10492730
10696855
10696857
10697306
Model or catalog number
10492730
RAPIDPOINT 500
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES