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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00186-1
Product Name/Description Elecsys Anti-HAV assay run on the Elecsys 2010 and cobas e 411 analysers, cobas e 601/602 modules and Modular Analytics E-Module. An in vitro diagnostic medical device (IVD).

Material Number: 04854977190

All Lots

ARTG number: 268492
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/02/2017
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Roche have determined that the performance of the Elecsys Anti-HAV assay is affected by certain types of plasma specimens. When Li-heparin and Na-heparin plasma specimens were compared to serum samples during internal investigations, the specified required recovery could not be achieved. Values were found to be on average up to 35 % below those obtained in serum. This under-recovery may occur across the entire measuring range. A false negative result may occur only where heparin plasma samples are within close proximity to the medical decision point of the assay at 20 IU/L. In all other cases, interpretation of the results would be unchanged. Based on these findings, Li- and Na-heparin plasma specimens will no longer be claimed to be acceptable specimen types in the IFU. In addition, for K3-EDTA & citrate plasma specimens, the specified criterion in the IFU that the recovery compared to serum specimens has to be within 90-110 % has been broadened to 80-120 %.
Recall Action Recall for Product Correction
Recall Action Instructions The Elecsys Anti-HAV IFU will be updated to remove Li-heparin or Na-heparin plasma as acceptable specimen types and to include the following limitation: For plasma treated with lithium heparin or sodium heparin, the values found were up to 35 % lower than those obtained in serum. In addition, for the acceptable specimen types K3-EDTA and sodium citrate plasma, the criterion for mean recovery will be updated to 80-120 % of serum value.

Users are advised to take note of the updated limitations and not use Li-heparin or Na-heparin plasma specimens with the assay. Laboratories should also consider retesting in accordance with relevant clinical information, if they suspect discrepant results with Li- and Na-heparin plasma specimens or have specific questions.

This action has been closed out on 25/09/2018
Contact Information 02 9860 2357 - Roche Diagnostics