Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMMULITE 2000 Recalled by Siemens Medical Solutions Diagnostics Due to There is a potential for incorrect results 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 Medical Solutions Diagnostics directly.
Affected Products
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Quantity: 1006 units
Why Was This Recalled?
There is a potential for incorrect results to be reported from processing of a sample tube.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Medical Solutions Diagnostics
Siemens Medical Solutions Diagnostics has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report