Siemens IMMULITE 2000 HCG Test Systems May Give False High hCG Results
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.
Lower-risk recall
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61073-siemens-immulite-2000-hcg-test-systems-may-give-false-high.
Source Summary by GovInfoNow · govinfonow.com/recall/61073-siemens-immulite-2000-hcg-test-systems-may-give-false-high · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1015-2022
Cite this page
“Siemens IMMULITE 2000 HCG Test Systems May Give False High hCG Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61073-siemens-immulite-2000-hcg-test-systems-may-give-false-high. Based on FDA recall #Z-1015-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1015-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Product
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number- Category
Medical device
What to do — step by step
Check Product Details
Look for the product name, material number, and production lot number on the test system to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Indiana, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1015-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1015-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.