Medical device manufacturer, Roche Diagnostics, has issued a field safety notice concerning its Elecsys Anti-HAV [Device identifier: 04854977190; Lot number: All].
The manufacturer has determined that the performance of the Elecsys Anti-HAV assay is impacted by certain types of plasma specimens. Therefore, the claim in the method sheet regarding acceptable specimens under 'Specimen collection and preparation' will be corrected. Li- and Na-heparin specimens will no longer be acceptable specimen types.
According to the manufacturer, when Li-heparin and Na-heparin plasma specimens were compared to serum samples during internal investigations the specified required recovery could not be achieved. If Li-heparin or Na-heparin plasma specimens are used, erroneous negative anti-HAV results are possible. Taking into consideration the high frequency of occurrence and difficult detectability of the issue, a relevant medical risk cannot be excluded. On the other hand, internal investigations have determined that the usage of K3-EDTA plasma specimens does not carry the risk of generating erroneous results.
The manufacturer advises affected users to consider the limitations of the new 'Specimen collection and preparation' wording in the assay instructions as listed in the field safety notice. In case users suspect discrepant results with Li- and Na-heparin plasma specimens or have specific questions, re-testing might be advisable in concordance with relevant clinical information.
According to the local supplier, the affected products are distributed in Hong Kong.
The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has also posted a medical device safety alert concerning similar issue. For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-30-january-3-february-2017
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 8 February 2017