Immulite Systems - Androstenedione Assay (2013-12-24)

Starting date:

December 24, 2013

Posting date:

February 10, 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-37837

• 
  Reason
• 
  Affected products

Recalled Products

A.  Immulite 2000 System - Androstenedione Assay

B. Immulite System - Androstenedione Assay

C. Immulite 1000 System - Androstenedione Assay

Reason

Siemens Healthcare Diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL. Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the instructions for use (IFU). Quality control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.

Affected products