Siemens Healthcare Diagnostics Products Ltd.: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Recall Summary Siemens Healthcare Diagnostics is recalling Immulite 2000 Systems syphilis screening tests because the assay may incorrectly report some positive or low-reactive syphilis results as negative. The affected test kits were distributed nationwide in the U.S. and in multiple countries worldwide. Healthcare facilities and laboratories using these specific test lots should check if they have the recalled products.
- Recalling firm
- Siemens Healthcare Diagnostics Products Ltd.
- Product
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- Reason
- Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/08b12394-c50f-4430-87f2-141b34b66b10