Roche recalls Elecsys Anti-TSHR immunoassay kits due to inconsistent results across instruments and calibrator variations, which may lead to delayed or incorrect thyroid treatment. Affected lots: 08496633190 (exp 02/26), 08496633190 (exp 10/26), 08496609190 (exp 05/26).
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Roche is recalling certain Elecsys Anti-TSHR immunoassay kits because they can produce inconsistent results across different instruments and between calibrator batches. This may lead to delayed or incorrect thyroid treatment decisions, which could affect patient care.
The test kits can produce inconsistent results depending on the instrument used and between different batches of calibrators. This inconsistency may lead to delayed or incorrect diagnosis of thyroid conditions, potentially causing treatment delays or errors.
Healthcare providers using the Elecsys Anti-TSHR immunoassay kits for thyroid hormone testing are affected. Patients receiving thyroid treatment based on these kits may be at risk of incorrect diagnosis or delayed treatment.
Check the lot numbers on the kit packaging: 08496633190 (expires 02/26), 08496633190 (expires 10/26), or 08496609190 (expires 05/26). These kits were sold with specific expiration dates.
Look for lot numbers 08496633190 (exp 02/26), 08496633190 (exp 10/26), or 08496609190 (exp 05/26) on the product packaging.
The recall is due to inconsistent results across different instruments and between calibrator batches, which may lead to delayed or incorrect thyroid treatment.
The official recall notice does not specify a remedy, so affected users should check the lot numbers and contact Roche for guidance.
The recall indicates potential for delayed or incorrect diagnosis, but no immediate safety risks like injury or fire are mentioned.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1009-2026 — Roche Roche Hello, I own a Roche that is covered by recall Z-1009-2026 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.
