Home › Abbott GmbH › ARCHITECT
ARCHITECT
Abbott GmbH · Model 8D06-13 · UDI-DI 00380740103545
1
510(k) clearances
492
Adverse events
18
Recalls
28
Facilities
Description
ARCHITECT Syphilis TP Controls
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.