Roche recalls Elecsys Anti-TPO Assay for cobas e 411/601/602 analyzers due to RF interference claims not meeting standards. All current and upcoming lots affected.
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
Roche is recalling Elecsys Anti-TPO Assay kits for cobas e 411, 601, and 602 analyzers because recent tests show the RF interference claims no longer hold. This could lead to inaccurate test results if the assay is used without proper calibration.
The assay's RF interference claims no longer meet current standards, meaning it might not work correctly with the analyzers. This could cause inaccurate test results if the device isn't properly calibrated or maintained.
Lab users with cobas e 411, 601, or 602 analyzers and Elecsys Anti-TPO Assay kits (catalog number 06368590190) are affected. Those using the assay without verifying RF interference may get inaccurate results.
Check for the Elecsys Anti-TPO Assay on cobas e 411, 601, or 602 analyzers with catalog number 06368590190. All current and upcoming lots are included in this recall.
Check if your assay meets the updated RF interference standards for the cobas e analyzers.
No, this recall is for potential inaccurate test results due to RF interference claims not meeting standards. It does not pose a risk of injury.
No, you can continue using the assay as long as you verify RF interference standards are met for your specific analyzer model.
Check if your assay meets the updated RF interference standards for the cobas e analyzers. If not, contact Roche for guidance.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2981-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-2981-2020 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
