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Immulite and Immulite 1000 Systems (2013-11-07)
- Starting date:
- November 7, 2013
- Posting date:
- December 4, 2013
- 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-37011
Recalled products
- Immulite System - Folic Acid Assay
- Immulite 1000 System - Folic Acid Assay
Reason
Siemens Healthcare Diagnostics identified the potential for an accelerated decline in counts per second for the Immulite/Immulite 1000 folic acid (LKFO1) kit lots 335, 336, and 337. This may lead to a failed adjustment before the expiration date, which is indicated on the kit label, is reached.
Affected products
A. Immulite System - Folic Acid Assay
Lot or serial number
- 335
- 336
- 337
Model or catalog number
- LKFO1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B. Immulite 1000 System - Folic Acid Assay
Lot or serial number
- 335
- 336
- 337
Model or catalog number
- LKFO1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM