| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01093-1 |
| Product Name/Description |
UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)
UniCel DxH 600
Reference Numbers: 629029, B24465, B24802, B68304
UniCel DxH 800
Reference Number: B23858
All software versions
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has identified the possibility of specimen mis-identification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier
is configured to Tube Position ID. This issue does not occur if the primary identifier is configured as Specimen ID.
Results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the Worklist when the following sequence of events occurs:
- the Primary Identifier is Tube Position ID.
- a patient control file is setup for ID XXXXX, and a pending test order for a patient sample ID XXXXX is subsequently added to the Worklist.
- the patient control sample is analysed using cassette presentation, but that tube does not contain a barcode-labelled Specimen ID or the label cannot be read.
Upon analysis, the results from the analysed patient control tube will be associated with the patient sample that was pending on the Worklist and not the patient control file. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users to ensure there are no pending or active test orders in the worklist before analysing a patient control with a Tube Position ID. Beckman Coulter is investigating the issue in order to determine a resolution.
This action has been closed-out on 16/03/2018. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |