Health product recall

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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