ADVIA Chemistry System-Inorganic Phosphorus (IP) and (PI_C) Assay and Atellica Ch Inorganic Phosphorus (2020-03-30)
- Starting date:
- March 30, 2020
- Posting date:
- April 17, 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-72805
Last updated: 2020-04-17
Affected Products
- ADVIA Chemistry System-Inorganic Phosphorus (IP) Assay
- ADVIA Chemistry System-Inorganic Phosphorus (IP_C) Assay
- Atellica Ch Inorganic Phosphorus
Reason
Siemens Healthcare Diagnostics has identified that in certain disease states, where significantly elevated m-protein (paraprotein) levels occur, there is a potential for interference in inorganic phosphorus assay from specific monoclonal m-proteins resulting in falsely elevated results. The paraprotein interference issue is not reagent lot-specific and the issue is limited to patients with monoclonal gammopathies. Paraproteins may precipitate after reagent addition and may product falsely elevated IP results or high absorbance flags (root cause). Quality control will not alert the user to the issue. The ADVIA Chemistry Inorganic Phosphorus (IP) and Inorganic Phosphorus Concentrated (IP_C) assays, and ATELLICA CH Inorganic Phosphorus (IP) assay instructions for use (IFUs) do not include limitations for paraprotein interference.
Affected products
A. ADVIA Chemistry System-Inorganic Phosphorus (IP) Assay
Lot or serial number
- 471267
- 452823
- 460188
- 467231
- 471274
- 477447
- 477651
- 484461
- 484659
- 489369
Model or catalog number
- 3056927
- 7506099
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA Chemistry System-Inorganic Phosphorus (IP_C) Assay
Lot or serial number
- 467756
- 496015
- 452828
- 484664
Model or catalog number
- 6860523
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
C. Atellica Ch Inorganic Phosphorus
Lot or serial number
- 290900
- 291021
- 280668
- 280778
- 280781
- 280809
- 290854
- 290941
- 290977
Model or catalog number
- 11097611
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES