Ci-Tro Heparin Controls Low and High (2018-12-18)

Starting date:

December 18, 2018

Posting date:

January 11, 2019

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-68742

• 
  Reason
• 
  Affected products

Affected products

Ci-Tro Heparin Controls Low and High

Reason

Siemens healthcare diagnostics has confirmed that the APTT ratio of the Dade Ci-Trol Heparin Control Low lot 548455 may recover below the expected range for the APTT ratio given within the instructions for use (ratio for Sysmex CA-1500 systems: 1.4 - 2.2). Internal investigation with this specific Dade Ci-Trol Heparin Control Low lot confirmed that the content of unfractionated heparin is very low. This may lead to a low recovery of the APTT ratio with most APTT reagents and also to non-detectable heparin neutralization after treatment with Dade Hepzyme. This renders this control lot unsuitable for some of the intended uses given in the instruction for use.

Affected products