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Advia Chemistry System Products
- Starting date:
- January 16, 2013
- Posting date:
- February 4, 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-20247
Recalled Products
- Advia Chemistry System – Alkaline Phosphatase (ALPAMP) Assay
- Advia 1200 Chemistry System – Alkaline Phosphatase (ALPAMP) Assay
Reason
There is an increased incidence of absorbance flags (u, u, or ////) on some ALPAMP and ALPDEA reagent wedges, which in some cases can impede reporting of results. No QC shift or discrepant patient results are observed.
Affected products
A. Advia Chemistry System – Alkaline Phosphatase (ALPAMP) Assay
Lot or serial number
- 255406
- 260121
Model or catalog number
03035814
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
B. Advia 1200 Chemistry System – Alkaline Phosphatase (ALPAMP) Assay
Lot or serial number
- 255406
- 260121
Model or catalog number
03035814
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.