IMMULITE and IMMULITE 1000 System- Prostate-Specific Antigen (PSA) Assay (2018-07-19)
- Starting date:
- July 19, 2018
- Posting date:
- July 27, 2018
- 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-67324
Affected products
A. IMMULITE System- Prostate-Specific Antigen (PSA) Assay
B. IMMULITE 1000 System - Prostate-Specific Antigen (PSA) Assay
Reason
Siemens healthcare diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 and IMMULITE 2000/ IMMULITE 2000 XPi Prostate Specific Antigen (PSA) Assays are not meeting the current high-dose hook effect expectation in the Instructions For Use (IFU) and may result in falsely depressed results. Final revised hook value limits have been determined. The final revised high-dose hook effect will be updated in the IMMULITE / IMMULITE 1000/2000 PSA instructions for use.
Affected products
A. IMMULITE System- Prostate-Specific Antigen (PSA) Assay
Lot or serial number
0450
Model or catalog number
LKPS1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B. IMMULITE 1000 System - Prostate-Specific Antigen (PSA) Assay
Lot or serial number
0450
Model or catalog number
LKPS1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM