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Siemens Healthcare Diagnostics Inc. Products
- Starting date:
- November 26, 2012
- Posting date:
- January 7, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16521
Recalled Products
A. Chek-Stix
B. Clinitek Atlas Automated Urine Chemistry System - Positive Control Strips
Reason
The Clinitek Atlas positive control and Chek-Stix positive control for leukocyte reconstituted fails to meet IFU claims. When these lots (mentioned above) of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25º C (77º F).
Affected products
A. Chek-Stix
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10310482, 10310483
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
B. Clinitek Atlas Automated Urine Chemistry System – Positive Control Strips
Lot or serial number
S9094081A, S0097091C, S0100101B, S0103042A, S0103042H, S0106062A, S9101022B, S9105052A
Model or catalog number
10311124
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.