Health product recall

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

  1. ADVIA Chemistry System-Inorganic Phosphorus (IP) Assay
  2. ADVIA Chemistry System-Inorganic Phosphorus (IP_C) Assay
  3. 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