FDA Device recall Z-2965-2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly by Siemens Healthcare Diagnostics Products, citing syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2965-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-13 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Healthcare Diagnostics Products |
| Distribution | US |
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Reason
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Identifiers
| code_info | Lot Code: D387/UDI: 00630414976891 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2965-2026%22
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