ROTEM delta (2018-05-12)
- Starting date:
- May 12, 2018
- Posting date:
- March 15, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Identification number:
- RA-69304
Affected Products
ROTEM delta
Reason
A defect in the ROTEM delta marketing brochure ""pocket guide"" was noted with the A10 normal ranges that were inconsistent with ranges used in the submission documents and software version 2.7. The ranges used in submission documents and software v2.7 were based on clinical studies in the US. However, the A10 normal ranges used in the guide were inadvertently taken from the EU studies.
Affected products
ROTEM delta
Lot or serial number
Software versions prior to 2.9.1.
Model or catalog number
200100-CA
Companies
- Manufacturer
-
TEM Innovations GmbH
Martin-Kollar-Straße 13-15
Munich, Bavaria
81829
GERMANY