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Access Syphilis Reagent

Beckman Coulter, Inc. · Model C80411 · UDI-DI 15099590763626

LIP Prescription

510(k) clearances

495

Adverse events

Recalls

Facilities

Description

The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies to Treponema pallidum in human serum and plasma using the Access Immunoassay Systems. It is intended to be used as an aid in the diagnosis of syphilis or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. The Access Syphilis assay is not intended for blood and tissue donor screening.

Recalls

Date	Firm	Reason
2026-07-13	Siemens Healthcare Diagnostics Products Ltd.	Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
2026-07-13	Siemens Healthcare Diagnostics Products Ltd.	Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
2022-04-14	Bio-Rad Laboratories, Inc.	Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
2022-02-08	Bio-Rad Laboratories, Inc.	Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challeng
2022-02-08	Bio-Rad Laboratories, Inc.	Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challeng
2021-09-17	Bio-Rad Laboratories, Inc.	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may
2021-09-17	Bio-Rad Laboratories, Inc.	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may
2021-04-21	Siemens Healthcare Diagnostics, Inc	Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following
2020-04-21	Bio-Rad Laboratories, Inc.	The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
2014-11-17	Clark Laboratories, Inc. (dba,Trinity Biotech USA)	Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled exp

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.