Rotem ex-tem Thromboelastometry with Extrinsic Activation (2019-07-19)

Starting date:

July 19, 2019

Posting date:

August 2, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70615

Last updated: 2019-08-02

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  Reason
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  Affected products

Affected Products

Rotem ex-tem Thromboelastometry with Extrinsic Activation

Reason

Manufacturer received customer complaints on lot # 42255801 of Rotem ex-tem, reporting prolonged clotting times (CT) with multiple lots of ROTROL N controls.  Internal testing has also demonstatred prolonged ex-tem CT results outside of the normal range for healthy donor whole blood samples. This could potentially result in patients being inappropriately treated.

Affected products