SYNCHRON SYSTEMS (2015-09-08)

Starting date:

September 8, 2015

Posting date:

October 5, 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-55216

• Reason
• Affected products

Affected Products

1. Uric Acid Reagent (URIC)
2. Synchron Systems Enzymatic Creatinine Reagent (CR-E)

Reason

N-Acetyl Cysteine (NAC) has been identified as an interference source for certain assays involving Trinder Chemical Pathways. Beckman Coulter initiated an investigation to determine if the interference would be observed in the DxC Synchron products that utilize trinder reaction. The results from the study showed that CR-E and uric reagents are significantly affected by therapeutic levels of N-Acetyl Cysteine. NAC is currently not listed as an interferent in the chemistry information sheets for CR-E or for uric, which may lead to false low results for CR-E and uric to be generated.

Affected products