ROTEM ROTROL N NORMAL CONTROL FOR THROMBOELASTOMETRY (2019-07-10)

Starting date:

July 10, 2019

Posting date:

August 2, 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-70579

Last updated: 2019-08-02

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  Reason
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  Affected products

Affected Products

ROTEM ROTROL N NORMAL CONTROL FOR THROMBOELASTOMETRY

Reason

TEM Innovations has identified that a target range reassignment is necessary for lot no. 42235001 Of ROTEM ex-tem, when used in conjunction with lot nos. 42242401, 42261401 And 42190401 of ROTEM delta ROTROL N. Therefore, a new quality certificate is being provided as part of this communication.

Affected products