Siemens Healthcare recalls IMMULITE 2000 HCG test systems that may produce falsely elevated hCG results due to sample carryover. Affected units include specific 200-test and 600-test models with production lots 463-472.
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Siemens Healthcare is recalling its IMMULITE 2000 HCG test systems that may give falsely high hCG results. This could lead to incorrect pregnancy tests or health decisions if the test is used on samples with carryover from previous tests.
The test system may produce falsely elevated hCG results when sample carryover occurs between patient samples and quality control samples. This happens because the test system doesn't properly clean out previous samples, leading to inaccurate readings.
Lab users and healthcare providers who operate the IMMULITE 2000 HCG systems with the affected production lots. Pregnant individuals using these systems for home pregnancy testing may be at risk of false positives.
Check for the product name 'IMMULITE 2000 HCG' with either 200 tests (material number 10381206) or 600 tests (material number 10381194). Affected units include production lots 463 through 472.
Look for the product name, material number, and production lot number on the test system to confirm if it's affected.
The IMMULITE 2000 HCG test system may produce falsely elevated hCG results due to sample carryover between patient samples and quality control samples.
Check the product details to see if it's affected. If it is, contact Siemens Healthcare for guidance on next steps.
Affected units include the IMMULITE 2000 HCG with 200 tests (material number 10381206) or 600 tests (material number 10381194) and production lots 463 through 472.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1015-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1015-2022 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.
