FDA Adverse Event Malfunction Summary report: N

ALINITY I SYPHILIS TP REAGENT KIT

MDR report key: 24915699 · Received April 17, 2026

Report

Report Number: 3002809144-2026-00098
Event Type: Malfunction
Date Received: April 17, 2026
Date of Event: April 10, 2026
Report Date: April 17, 2026
Manufacturer: ABBOTT GMBH
Product Code: LIP
UDI-DI: 00380740161927
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P60-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P60-21/31, AND 510K/PMA/BLA OF K153730.

Description of Event or Problem · 0

THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I SYPHILIS TP RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 67-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY OF JOINT INFLAMMATION, HYPERTENSION, AND DIABETES. THE ALINITY I RESULT WAS NOT CONSISTENT WITH RESULTS OBTAINED USING OTHER TESTING METHODS. THE FOLLOWING DATA WERE PROVIDED (< 1.00 S/CO = NONREACTIVE; = 1.00 S/CO = REACTIVE): SID (B)(6_: ALINITY I SYPHILIS TP RESULT = 0.54 S/CO (NONREACTIVE) AUTOBIO CHEMILUMINESCENCE RESULT = 6.4 S/CO (REACTIVE) TPPA RESULT = POSITIVE TRUST RESULT = NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
975587	ALINITY I SYPHILIS TP REAGENT KIT	ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM	LIP	ABBOTT GMBH		83335BE01	00380740161927

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR	Female		ALNTY I PROCESSING MODU, 03R65-01, (B)(6).