FTD Respiratory Pathogens 21 (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-72761
Last updated: 2020-04-16
Affected Products
FTD Respiratory Pathogens 21
Reason
Inform customers of performance issues related to absence of validation and verification records for the performance claims of the Respiratory Pathogens 21 products after a design change in november 2015 affecting the products indicated.
Affected products
FTD Respiratory Pathogens 21
Lot or serial number
- RE18-64-115
- RE18-64-116
- RE18-64-118
- RE19-64-01
- RE19-64-12
- RE19-64-20
- RE19-64-23
- RE19-64-29
Model or catalog number
- FTD-2-32
- FTD-2-64
Companies
- Manufacturer
-
Fast Track Diagnostics Luxembourg S.A.R.L.
29 rue Henri Koch
Esch-sur-Alzette
4354
LUXEMBOURG