Siemens Healthcare recalls ADVIA Centaur TSH3-Ultra thyroid tests with specific catalog numbers and lot numbers due to potential reduced dilution recovery or inoperability when used with certain reagents.
In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
Siemens Healthcare is recalling specific models of ADVIA Centaur TSH3-Ultra thyroid tests. These tests may not work properly with certain reagents, leading to inaccurate results or equipment failure.
The analyzers may show reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and specific lots of BNP and TSH3RUL Assays. This could lead to inaccurate test results or equipment malfunction.
Laboratories using the recalled ADVIA Centaur TSH3-Ultra tests with catalog numbers 06491072, 06491080, or 04862625 and lot numbers ending in 298 or 301 are most at risk. These are typically medical labs that perform thyroid hormone testing.
Check the catalog number on the test kit (06491072 for 100 tests, 06491080 for 500 tests, 04862625 for 2500 tests) and the lot number (ending in 298 or 301).
Verify the catalog number on the test kit: 06491072 (100 tests), 06491080 (500 tests), or 04862625 (2500 tests).
Ensure the lot number ends in 298 or 301 to identify affected units.
The analyzers may show reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
Check the catalog number (06491072, 06491080, or 04862625) and lot number (ending in 298 or 301).
The recall does not specify a remedy, so contact Siemens Healthcare for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2054-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2054-2018 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.
