CVM Material for Calibration Verification of Blood Gas, Electrolyte, Total Hemoglobin, Bilirubin, and Metabolite Systems (2018-07-16)
- Starting date:
- July 16, 2018
- Posting date:
- August 2, 2018
- 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-67336
Affected products
- 850/855 BLOOD GAS SYSTEM - CONTROL REAGENTS
- 840/845 BLOOD GAS SYSTEM - CONTROL REAGENTS
- 348 SYSTEM - REAGENTS
- 860/865 BLOOD GAS SYSTEM - CONTROL REAGENTS
- CVM Material
Reason
Siemens Healthcare Diagnostics has confirmed that the CVM level 1 pCO2 and/or tHb results may recover low within range or lower than expected with the lots 350701 and 350702 of CVM.
These lower recoveries may be observed on both the RAPIDPoint and the RAPIDLab Blood Gas Systems. CVM levels 2 through 5 are not affected.
Affected products
A. 850/855 BLOOD GAS SYSTEM - CONTROL REAGENTS
Lot or serial number
Lot 350701 and 350702
Model or catalog number
- 10316535
- 116189
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
B. 840/845 BLOOD GAS SYSTEM - CONTROL REAGENTS
Lot or serial number
Lot 350701 and 350702
Model or catalog number
- 10316535
- 116189
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
C. 348 SYSTEM - REAGENTS
Lot or serial number
Lot 350701 and 350702
Model or catalog number
- 10316535
- 116189
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
D. 860/865 BLOOD GAS SYSTEM - CONTROL REAGENTS
Lot or serial number
Lot 350701 and 350702
Model or catalog number
- 10316535
- 116189
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
E. CVM Material
Lot or serial number
Lot 350701 and 350702
Model or catalog number
- 02147872
- 10316535
- 116189
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES