Staclot LA (2018-11-12)

Starting date:

November 12, 2018

Posting date:

November 30, 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-68488

• 
  Reason
• 
  Affected products

Affected products

A. STA SYSTEM - LUPUS ANTICOAGULANT TESTING

B. STA-R EVOLUTION SYSTEM - STACLOT - LUPUS ANTICOAGULANT TESTING

Reason

Several customers outside have reported shortened (t1-t2) results, where some instances of results recovery outside of the range of less than 15 seconds for STA-Control LA2 have been observed (this range is specified on the kit value sheet).

Affected products