Health product recall

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

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

Rotem ex-tem Thromboelastometry with Extrinsic Activation

Lot or serial number

42255801

Model or catalog number

503-05-CA

Companies
Manufacturer

TEM Innovations GMBH

Martin-Kollar-Straße 13-15

Munich, Bavaria

81829

GERMANY