Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Read the official notice →- Date
- 2026-08-26
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics Products Ltd.
- Product
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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