Class II — Siemens Healthcare Diagnostics Products Ltd.
| Recalling firm | Siemens Healthcare Diagnostics Products Ltd. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. |
| Product | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly |
| Quantity | 478 units |
| 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, RussianFed., SaudiArabia, Slovakia, Slovenia, SouthAfrica, Spain, U.A.E., Ukraine, UnitedKingdom, Uzbekistan. |
| Initiated | 2026-07-13 |
| Classified | 2026-08-14 |
| Recall number | Z-2966-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics Products Ltd. (Z-2966-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99447/
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