| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00596-1 |
| Product Name/Description |
MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD).
Catalogue Number: CHU-1
Lot Number: CHU20021A
ARTG Number: 192625
(Thermo Fisher Scientific Australia Pty Ltd - Multiple clinical chemistry constituent IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
29/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
The control's open-vial stability claim for all constituents is "Once opened, vials of chemTRAK - H are stable for 14 days when stores tightly capped at 2-8Deg C". The manufacturer has confirmed that one constituent of the control, Glucose, does not meet this stability claim as the recovery of this constituent trends down prior to the stated open-vial usage.
The open-vial stability claim of 14 days remains unchanged for the other glucose levels, CHU20022A and CHU20023A. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Thermo Fisher are advising customers to continue to use Level 1 of the chemTRAK control after the initial thaw for a period of 5 days and discard the control after this period.
This action has been closed out on the 15/11/2018. |
| Contact Information |
03 9757 4300 - Thermo Fisher Australia |