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Immulite System - Cortisol Assay (2014-09-24)
- Starting date:
- September 24, 2014
- Posting date:
- October 2, 2014
- 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-41629
Recalled Products
A) Immulite 1000 System - Cortisol Assay
B) Immulite System - Cortisol Assay
Reason
Siemens has received customer complaints one positive control bias observed on Immulite/Immulite 1000 Cortisol LKCO 381, 382 and 383. Internal investigation confirmed a positive bias and control bias observed on the Immulite/Immulite 1000 Cortisol LKCO kit lots 381, 382 and 383.
Affected products
A) Immulite 1000 System - Cortisol Assay
Lot or serial number
381
382
383
Model or catalog number
LKCO1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B) Immulite System - Cortisol Assay
Lot or serial number
381
382
383
Model or catalog number
LKCO1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM