FTD Pneumocystis Jirovecii and FTD Viral Gastroenteritis (2020-01-10)
- Starting date:
- January 10, 2020
- Posting date:
- April 16, 2020
- 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-72757
Last updated: 2020-04-16
Affected Products
- FTD Pneumocystis Jirovecii
- FTD Viral Gastroenteritis
Reason
Performance issues related to absence of validation and verification records for the performance claims of the FTD Viral Gastroenteritis FTD-3-32, FTD-3-64) and FTD Pneumocystis Jirovecii FTD-27-32, FTD-27-64).
Affected products
A. FTD Pneumocystis Jirovecii
Lot or serial number
All lots.
Model or catalog number
- FTD-27-32
- FTD-27-64
Companies
- Manufacturer
-
Fast Track Diagnostics Luxembourg S.A.R.L.
29 rue Henri Koch
Esch-sur-Alzette
4354
LUXEMBOURG
B. FTD Viral Gastroenteritis
Lot or serial number
All lots.
Model or catalog number
- FTD-3-32
- FTD-3-64
Companies
- Manufacturer
-
Fast Track Diagnostics Luxembourg S.A.R.L.
29 rue Henri Koch
Esch-sur-Alzette
4354
LUXEMBOURG