CVM (2020-05-08)
- Starting date:
- May 8, 2020
- Posting date:
- May 22, 2020
- 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-73165
Last updated: 2020-05-29
Affected Products
CVM
Reason
Siemens Healthcare Diagnostics has confirmed an error in the calibration verification material (CVM) material performance variability range pertaining to the level 2 lactate range on the Siemens Rapidpoint 500/500E blood gas systems in the specified kit lots only. The error is caused by inadvertent value mis-assignment.
Affected products
CVM
Lot or serial number
350119
350219
350802
350802R
350803
Model or catalog number
10316535
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES