Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00627-1
Product Name/Description	Synchron Systems Microalbumin (MA) Reagent Reference Number: 475100 Lot Number: M609458 Expiry Date: 30 Sep 2018 ARTG Number: 213984
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/05/2017
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. Internal testing has confirmed that MA is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2. As a result, patient results with MA Reagent Lot M609458 may be up to 0.5 mg/dL lower than actual values. In addition, lower recovery of MA in Urine Protein Control Level 1 may cause MA to exceed the lower limits of a laboratory's established QC range.
Recall Action	Recall
Recall Action Instructions	Beckman Coulter is advising users to discontinue use and discard MA Reagent Lot M609458 following their laboratory's disposal protocol. Replacement product will be provided. This action has been closed out on the 25/09/2018.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre