Health product recall

IMMULITE System and 1000 System - Turbo Intact PTH Assay (2018-03-26)

Starting date:
March 26, 2018
Posting date:
May 11, 2018
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-66718

Affected products

  1. IMMULITE SYSTEM - TURBO INTACT PTH ASSAY
  2. IMMULITE 1000 SYSTEM - TURBO INTACT PTH ASSAY

Reason

Siemens Healthcare Diagnostics has confirmed the potential for failed adjustment slopes (Greater than 1.8) for the IMMULITE 1000 Turbo IPTH (LSKPTZ) Assay with the kit lots 246, 247, and 248.

Affected products

A. IMMULITE SYSTEM - TURBO INTACT PTH ASSAY

Lot or serial number

247

Model or catalog number

LSKPTZ

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM

B. IMMULITE 1000 SYSTEM - TURBO INTACT PTH ASSAY

Lot or serial number

247

Model or catalog number

LSKPTZ

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM