This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
AUTOMATICQC CARTRIDGE
- Starting date:
- September 15, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public
- Identification number:
- RA-60442
Affected Products
Reason
Siemens Healthcare Diagnostics has confirmed that the lots of Automatic QC Cartridge (AQC) listed have been incorrectly value assigned resulting in a +0.8 g/dl bias for level 1 total hemoglobin (tHb) on RapidPoint 400/405/500 Systems. Some users are reporting higher than expected results for this AQC level. AQC tHb levels 2 and 3 and all other AQC parameters are not affected.
Affected products
AUTOMATICQC CARTRIDGE
Lot or serial number
- AQC/19516
- AQC/19616
- AQC/20816
- AQC/20916
- AQC/21016
- AQC/21416
- AQC/21516
Model or catalog number
- 10310323
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES