Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-01619-1 |
Product Name/Description |
UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). An in vitro diagnostic medical device (IVD).
Wash Concentrate II
Reference Number: 445865
Lot Numbers: Z505212 (expiry 30 April 2017), Z507201 (expiry 30 June 2016), Z511202 (expiry 31 October 2017)
ARTG Number: 245295 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
13/12/2016 |
Responsible Entity |
|
Reason/Issue |
Beckman Coulter has determined that certain lots of DxC Wash Concentrate II can cause a failure in calibration of Thermo-Fisher Lithium reagent (Ref A19611). The consequence of calibration failure does not allow for patient results to be generated. Lithium calibration failure can potentially lead to a delay of reporting Lithium results. Patient results reported under acceptable calibration and quality control evaluation are not affected by this issue. |
Recall Action |
Recall |
Recall Action Instructions |
Beckman Coulter is advising Thermo-Fisher Lithium assay users to discontinue use of affected DxC Wash Concentrate II lots and discard any unused reagent bottles. Replacement product will be provided. Reassessment of past results is not required. This action has been closed-out on 21/03/2018. |
Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |