i-STAT Kaolin ACT Cartridge (2017-12-21)

Starting date:

December 21, 2017

Posting date:

January 12, 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-65652

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  Reason
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  Affected products

Affected products

i-STAT Kaolin ACT Cartridge

Reason

Abbott Point of Care (APOC) has identified that the i-STAT kaolin act test may be prolonged immediately after the administration of an initial full dose aprotinin bolus of 400 kallikrein inhibitor units (kiu)/ml. Once the drug has fully distributed throughout the body there is no impact on the act result reported.

Affected products