Home › Device types › LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
FDA product code LIP · Class 2 · Microbiology
58
Registered devices
492
Adverse events
18
Recalls
35
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex — BIO-RAD LABORATORIES, INC.BIO-RAD — CLARK LABORATORIES, INC.Elecsys Syphilis — Roche Diagnostics GmbHTrinity Biotech — CLARK LABORATORIES, INC.Access Syphilis Reagent — Beckman Coulter, Inc.Bio-Stat — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Phoenix Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.ADVIA Centaur® SYPH — Siemens Healthcare Diagnostics Inc.Atellica IM Syph QC — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHIMMULITE® 2000 Systems SYP Syphilis Screen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBioPlex 2200 — BIO-RAD LABORATORIES, INC.Phoenix Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Phoenix Biotech — CLARK LABORATORIES, INC.Lumipulse G TP-N Immunoreaction Cartridges Set — FUJIREBIO INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.ARCHITECT — Abbott GmbHIMMULITE® Systems SYP CONTROL Syphilis Screen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent 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 ma |
| 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 ma |
| 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 anti |
| 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 anti |
| 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 im |
| 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 |
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