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Immulite 2000 System - Osteocalcin Assay (2014-01-20)

Starting date:
January 20, 2014
Posting date:
February 11, 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-37927

Recalled products

  1. Immulite 2000 System - Osteocalcin Assay

Reason

Siemens Healthcare Diagnostics has confirmed under recovery up to 50% in patient values with the Immulite 2000 / Immulite 2000 XPI Osteocalcin (l2KON2) kit lots 218, 219, 220 and 221. Quality control materials will not detect the bias.

Affected products

A. Immulite 2000 System - Osteocalcin Assay

Lot or serial number
  • 218
  • 219
  • 220
  • 221
Model or catalog number
  • L2KON2
Companies
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM