HemosIL Factor XII Deficient Plasma (2017-07-17)

Starting date:

July 17, 2017

Posting date:

March 13, 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-66136

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  Reason
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  Affected products

Affected products

HEMOSIL FACTOR XII DEFICIENT PLASMA

Reason

HemosIL Factor XII Deficient Plasma are not meeting their labeled on-board instrument stability claim for the ACL Top Family and ACL Top Family 50 Series of 24 hours at 15 C, the affected lots numbers are only stable for 2 hours on-board the instrument. Consequently, there is a potential risk of falsely lowered patient results if this reagent is maintain greater than 2 hours on-board the instrument.

Affected products