Siemens Healthcare recalls IMMULITE 2000 and 2000 XPi TSI kits that may produce false low thyroid results, risking delayed patient care. Affected kits have specific material numbers and expiration dates.
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
Siemens Healthcare is recalling IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) kits that may give false low results, potentially delaying proper treatment for thyroid conditions. This recall affects kits with specific material numbers and expiration dates.
These kits may produce false low thyroid results compared to other tested kits, which could lead to delayed follow-up for patients with autoimmune thyroid conditions. The issue is related to the test's accuracy rather than immediate safety risks.
Patients using these kits for thyroid testing may receive false low results, potentially delaying treatment. Healthcare providers using the kits are most at risk of incorrect patient outcomes.
Check for Siemens Material Number (SMN) 10876421 (US) or 10713448 (OUS) on the kit. The expiration date for affected kits is November 30, 2022.
Look for Siemens Material Number (SMN) 10876421 (US) or 10713448 (OUS) on the kit label.
These kits may produce false low thyroid results, potentially delaying proper treatment for autoimmune thyroid conditions.
Check for Siemens Material Number (SMN) 10876421 (US) or 10713448 (OUS) on the kit label, with an expiration date of November 30, 2022.
The recall does not require immediate discontinuation; affected kits should be checked for the specific material numbers and expiration date.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1820-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1820-2022 from Siemens Healthcare. 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.
