FDA Adverse Event Malfunction Summary report: N

ALINITY M RESP-4-PLEX AMP KIT

MDR report key: 24840566 · Received April 10, 2026

Report

Report Number: 3005248192-2026-00037
Event Type: Malfunction
Date Received: April 10, 2026
Date of Event: March 10, 2026
Report Date: May 14, 2026
Manufacturer: ABBOTT MOLECULAR, INC.
Product Code: QJR
UDI-DI: 00884999049390
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. ADDITIONAL MDR SUBMITTED FOR THE ADDITIONAL RUN DATE: 3005248192-2026-00036 16-MAR-2026

Description of Event or Problem · 0

THE CUSTOMER REPORTED TWO (02) FALSE POSITIVE RESULTS FOR THE RSV TARGET ON THE ALINITY M RESP-4-PLEX AMP KIT. PATIENT 1: SAMPLE ID (SID): (B)(6) WAS PROCESSED ON 16-MAR-2026 AND RESULTED AS RSV POSITIVE WITH A CYCLE THRESHOLD (CT) VALUE OF 39.11. REPEAT TESTING ON THE CEPHEID PLATFORM PRODUCED A NOT DETECTED RESULT FOR RSV. PATIENT 2 (15-MONTH OLD PATIENT): SID: (B)(6) WAS PROCESSED ON 10-MAR-2026 AND RESULTED AS RSV POSITIVE WITH A CT VALUE OF 39.10. REPEAT TESTING ON THE CEPHEID PLATFORM PRODUCED A NOT DETECTED RESULT. THE SPECIMEN TYPE WAS A NASOPHARYNGEAL (NP) SWAB COLLECTED IN BD UNIVERSAL VIRAL TRANSPORT (UVT). REPEAT TESTING WAS PERFORMED USING THE ORIGINAL SAMPLE TUBE. AT THE CUSTOMER SITE FOR MULTIPLEX ASSAYS IF TWO OR MORE TARGETS RETURN A POSITIVE RESULT, THE SAMPLE IS RETESTED ON ANOTHER PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
93062	ALINITY M RESP-4-PLEX AMP KIT	REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	QJR	ABBOTT MOLECULAR, INC.		444189	00884999049390

Patients

Seq	Age	Sex	Outcome	Treatment
1