ROTEM ROTROL N Normal Control for Thromboelastometry (2019-07-10)

Starting date:

July 10, 2019

Posting date:

August 9, 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-70639

Last updated: 2019-08-09

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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 (Part No. 503-05-CA), when used in conjunction with Lot Nos. 42242401, 42261401 and 42190401 of ROTEM delta ROTROL N (Part No. 503-24-CA).  Therefore, a new Quality Certificate is being provided as part of this communication.  Please use the new assigned ranges for Lot No. 42235001 of ROTEM ex-tem with ROTROL N Lot Nos. 42242401, 42261401 and 42190401.

Affected products