| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00604-1 |
| Product Name/Description |
VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).
Unique Identifier Number:10758750004690
Product Code: 8298671
Generation: GEN 16
Coating ID: Coating 0165
Multiple Lot Numbers
Expiry date:15 March 2018 through to 15 June 2018
ARTG Number: 245278
(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry therapeutic drug monitoring IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Ortho has confirmed customer complaints regarding the potential for imprecise results when using impacted VITROS PHYT Slides. The results obtained were either positively or negatively biased across the VITROS PHYT Slides measuring range of 3.00–40.00 ug/mL (11.88–158.40 umol/L).
To date, no adverse events have been reported as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Ortho is requesting customers to immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. Ortho will replace remaining inventory of the affected lots or credit accounts.
This action has been closed out on 05/01/2021 |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |