Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF — Class II medical device recall Z-2966-2026
Ongoing recall by Siemens Healthcare Diagnostics Products Ltd., reported 2026-08-26, distributed nationwide. Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being repo
| Recall number | Z-2966-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Products Ltd., Caernarfon, United Kingdom |
| Recall initiated | 2026-07-13 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BR, CL, CO, CY, DE, ES, FR, IT, LT, LV, NL, RO, SI, SK, UA |
| Quantity | 478 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414999807 |
| Lot numbers | D387 |
| Model numbers | L2KSY6/10488319IVD |
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Reason for recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2966-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.