| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00974-1 |
| Product Name/Description |
VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). An in vitro diagnostic medical device (IVD).
Product code: 8568040
Lot Number: 0954
Expiry Date: 31 May 2016
Unique Device Identifier Number: 10758750005031
ARTG number: 245278 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
The increase in U90-382 and 6LU condition codes primarily occurs when using VITROS DGXN and PHYT Slides. VITROS ACET and CRBM Slides are not affected. When the U90-382 or 6LU condition code occurs, the VITROS System suppresses the result and no result is reported. All numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits. |
| Recall Action |
Recall |
| Recall Action Instructions |
OCD is advising users to discontinue use and discard all remaining inventory of the affect lot. OCD will replace the affected units or provide a suitable credit. The affected lot may still be used until replacement lots are available. This action has been closed-out on 06/09/2016. |
| Contact Information |
1800 032 359 - Customer Technical Services |