FDA Adverse Event Malfunction Summary report: N

ARCHITECT SYPHILIS TP REAGENT KIT

MDR report key: 25027039 · Received April 29, 2026

Report

Report Number: 3002809144-2026-00109
Event Type: Malfunction
Date Received: April 29, 2026
Date of Event: April 20, 2026
Report Date: April 29, 2026
Manufacturer: ABBOTT GMBH
Product Code: LIP
UDI-DI: 00380740169954
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08D06, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41, WITH 510K/PMA/BLA NUMBER K153730. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem · 0

THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1: INITIAL RESULT = 0.93 S/CO, WEIGAO PLATFORM = 3.71, TPPA = POSITIVE, IMMUNOBLOT = FAINT BANDS FOR P15, P17, AND P47. SAMPLE 2: INITIAL RESULT = 0.39 S/CO, WEIGAO PLATFORM = 1.16, TPPA = WEAKLY POSITIVE SAMPLE 3: INITIAL RESULT = 0.90 S/CO, WEIGAO PLATFORM = 4.64, TPPA = POSITIVE SAMPLE 4: INITIAL RESULT = 0.91 S/CO, WEIGAO PLATFORM = 2.58, TPPA = WEAKLY POSITIVE SAMPLE 5: INITIAL RESULT = 0.74 S/CO, WEIGAO PLATFORM = 3.21, TPPA = WEAKLY POSITIVE SAMPLE 6: INITIAL RESULT = 0.46 S/CO, WEIGAO PLATFORM = 2.16, TPPA = POSITIVE, IMMUNOBLOT = FAINT BANDS FOR P15 AND P47 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
305613	ARCHITECT SYPHILIS TP REAGENT KIT	ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM	LIP	ABBOTT GMBH		83314BE02	00380740169954

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		ARC I2000SR INST, 03M74-02, (B)(6)