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Immulite 2000 Syphilis Screen Test System

by Siemens Healthcare Diagnostics

510(k) K091361

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091361 Date16 Dec 2009ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2965-2026 FDA Class II initiated 13 Jul 2026
    • Ongoing Z-2966-2026 FDA Class II initiated 13 Jul 2026

    Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LIP
Device Class
Class II
Regulation
21 CFR Part 866.3830
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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