IMMULITE SYSTEM (2014-10-17)

Starting date:

October 17, 2014

Posting date:

April 14, 2015

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-52895

• Reason
• Affected products

Recalled Products

A. IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) ASSAY

B. IMMULITE 1000 SYSTEM - FSH ASSAY

Reason

An internal complaint identified a barcode conflict between Immulite/Immulite 1000 follicle- stimulating hormone (FSH), LKFS reagent wedge lots 351 and 352 where both reagent wedge lots were displayed by the software as lot '01'. This could result in the incorrect reagent wedge lot being used for a kit lot if both reagent wedges were on the instrument at the same time. An internal investigation concluded that there would be no impact to patient or quality control results if reagent wedges were mis-matched. Customer complaint escalations identified "adjustment overdue" or "expired" flags when Immulite /Immulite 1000 FSH reagent lot 351 was stored in system history and reagent lot 352 was introduced to the system. The customer (field) confirmed "adjustment overdue" or "expired" flags could not be replicated internally. Note: kit lot 351 expired August 31, 2014, kit lot 352 expires October 31, 2014

Affected products