Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMMULITE 2000 Systems HCG [200 Tests Recalled by Siemens Healthcare Diagnostics, Inc. Due to Potential for falsely elevated hCG results due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Quantity: 10,755 boxes (533 US, 10,222 OUS)
Why Was This Recalled?
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report