| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01035-1 |
| Product Name/Description |
Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)
Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
Part Number: 33200
Lot Numbers: 595027 and 595029
Expiry Date: 15 Feb 2016 and 28 Feb 2016
ARTG Number: 213975 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that the Access CEA reagent packs were filled incorrectly. These packs contain insufficient quantity of reagents in one of the pack wells. The impact is dependent upon the instrument and software version installed at the time the reagent lot was in use:
Access 2 systems, software version 3.3.1 or lower, and Access 2i systems, software version 6.1 or lower:
- The instrument may have generated incorrect results of 0.0 ng/mL. All other results greater than 0.0 ng/mL are not affected by this issue and are correct.
Access 2 systems, software version 3.4.2 and Access 2i systems, software version 6.2.2 or higher:
- The affected packs would be detected by process monitoring, and the pack disabled by the instrument. No patient results generated.
UniCel DxI systems with all software versions:
- The packs wouldbe detected by reagent pack monitoring, and the pack disabled by the instrument. No patient results generated. |
| Recall Action |
Recall |
| Recall Action Instructions |
Beckman Coulter is advising users to discard any remaining stocks of the affected lots.
Beckman Coulter is recommending users review patients results that were reported as 0.0 ng/mL and did not match the clinical status of the patient, and advise clinicians at the discretion of the Laboratory Director. A software upgrade for Access systems to version 3.4.2 and Access 2i to version 6.2.2 rectifies this issue. This action has been closed-out on 02/05/2017. |
| Contact Information |
1800 060 881 - Customer Support Centre |