IMMULITE, 1000 and 2000 System- Progesterone Assay (2019-07-12)
- Starting date:
- July 12, 2019
- Posting date:
- July 26, 2019
- 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-70529
Last updated: 2019-07-26
Affected Products
IMMULITE, 1000 and 2000 System- Progesterone Assay
Reason
Siemens Healthcare Diagnostics INC. Has determined that there is a potential for low discordant progesterone results on a subset of patient samples. Our investigation of customer complaints suggests the presence of a potential interferent with the assay. Based on available data, it is estimated the occurrence is
Affected products
A. IMMULITE 1000 System- Progesterone Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LKPW1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B. IMMULITE 2000 System- Progesterone Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
L2KPW2
L2KPW6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
C. IMMULITE System- Progesterone Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LKPW1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
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