MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Model Number	SYPHILIS
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The elecsys htlv-i/ii result for patient 1 was obtained on a cobas e 801 analytical unit with serial number (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys htlv-i/ii and elecsys syphilis results for 1 patient and questionable elecsys syphilis results for 1 patient on a cobas e 801 analytical unit.Patient 1: the elecsys syphilis result was reactive on (b)(6) 2026, the (captia-g method) confirmatory syphilis test result was "confirmed non-reactive".The elecsys htlv-i/ii result was reactive.On (b)(6) 2026, the (western blot method) confirmatory htlv test result was "confirmed indeterminate".Patient 2: on (b)(6) 2026, the elecsys syphilis result was reactive the (captia-g method) confirmatory syphilis test result was "confirmed non-reactive".The samples were repeated because of the initially reactive results.This medwatch will apply to the elecsys syphilis assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys htlv-i/ii assay results for patient 1.

• Brand Name: ELECSYS SYPHILIS
• Common Device Name: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25333407
• Report Number: 1823260-2026-02127
• Device Sequence Number: 21302449
• Product Code: LIP
• UDI-Device Identifier: 07613336183083
• UDI-Public: 07613336183083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09015051162
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown