Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its Elecsys Anti-TPO assay on cobas e 411, cobas e 601, cobas e 602 [GMMI/Part Number Device Identifier: Elecsys Anti-TPO 06368590 190; Lot: All].
According to the manufacturer, the internal documentation of the Elecsys Anti-TPO assay on cobas e 411, cobas e 601 and cobas e 602 platforms was checked as part of ongoing preparations for the new EU IVD Regulation (IVDR). During internal verification studies it was found that the current method sheet claim for rheumatoid factors (RF) interference (no RF interference ≤1500 IU/mL) was not met. Re-testing showed that there is no RF interference ≤450 IU/mL (specifications of +/- 10% difference in recovery). For this reason, the method sheet of the assay will be updated accordingly. Elecsys Anti-TPO on cobas e801 is not affected and therefore no method sheet change is necessary. Due to the residual medical risk associated with this issue, affected users must be informed using the updated FSN.
Claim for rheumatoid factors will be changed and respective method sheets will be updated. The changed claim is applicable for all current and upcoming lots. Updated method sheets (V8) are expected to be available from September 2020.
Affected users are advised to consider the updated claim for rheumatoid factors interference (no RF interference ≤450 IU/mL) and should refer to the latest version of the method sheet (V8) as soon as it becomes available. In this case, no general recommendations with respect to the review of previous results are given, considering that the issue occurs only under special circumstances. Affected users should review their individual results with relevant clinical information if there are any specific questions.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 August 2020