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Total Protein 2 Reagent (Urine) for the Advia Chemistry Systems
- Starting date:
- May 23, 2013
- Posting date:
- July 23, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-34223
Recalled products
- Advia Chemistry Total Protein 2 (Urine) System
- Advia 1200 Chemistry Total Protein 2 System
Reason
Siemens Healthcare Diagnostics is conducting a recall for the Total Protein 2 Reagent (Urine)(UPRO2) lot 149411 on the Advia Chemistry systems. Due to precipitation of the reagent indicator dye in this lot, an increase in failed calibrations and quality control failures has been observed. These failures will result in no patient result being reported with the affected kits.
Affected products
A. Advia Chemistry Total Protein 2 (Urine) System
Lot or serial number
- 149411
Model or catalog number
- 05000171
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia 1200 Chemistry Total Protein 2 System
Lot or serial number
- 149411
Model or catalog number
- 05000171
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES