ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY(2015-08-31)

Starting date:

August 31, 2015

Posting date:

September 24, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-55032

• 
  Reason
• 
  Affected products

Affected Products

A. ACCESS SYSTEM - FREE T3 ASSAY

B. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY

C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY

Reason

Beckman Coulter has determined that some Access Free T3 Reagent Packs (P/N A13422) of lot 431433 were filled incorrectly. These packs contained insufficient quantity of reagents in one or more of the pack wells. Affected reagent packs have the potential to generate incorrect control and patient results dependent upon the instrument and software version installed at the time the reagent lot was in use.

Affected products