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
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
ROTEM ROTROL N NORMAL CONTROL FOR THROMBOELASTOMETRY
Lot or serial number
42190401
42242401
42261401
Model or catalog number
503-24-CA
Companies
- Manufacturer
-
TEM Innovations GMBH
Martin-Kollar-Straße 13-15
Munich, Bavaria
81829
GERMANY