ARCHITECT Syphilis TP Reagent Kit
Received Jul 28, 2026 · Event occurred Jul 12, 2026
Report 3002809144-2026-00204 · MDR key 50057381
Device
Generic name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Manufacturer
Abbott GmbhCatalog number
08D06-87
Lot number
83318BE01
Product problems
- False Negative Result
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer observed false nonreactive ARCHITECT Syphilis TP results that do not match Antibio platform. The results provided were: Initial=0.55 S/CO (< 1.00 S/CO=nonreactive)/repeated=0.60 S/CO. Another hospital=positive.Autobio platform= positive. TPPA=positive; RPR=negative. There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.Section A Patient Information: Refer to Section B5 for complete patient information. All available patient information was included. Additional patient details are not available.This report is being filed on an international product, list number 08D06-87, that has a similar product distributed in the US, list number 8D06-31 / 41, with 510K/PMA/BLA number K153730.