FDA Adverse Event Injury Summary report: N

APTIMA COMBO 2 ASSAY

MDR report key: 23245430 · Received October 8, 2025

Report

Report Number: 2024800-2025-00063
Event Type: Injury
Date Received: October 8, 2025
Date of Event: September 25, 2025
Report Date: October 8, 2025
Manufacturer: HOLOGIC, INC.
Product Code: LSL
PMA / PMN Number: K111409
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES; THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS LOW TARGET IN THE SAMPLE OR SAMPLE MISHANDLING. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

Description of Event or Problem · 0

ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULTS FOR SAMPLE ID (SID) (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY ML 9242340 ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6)). ON (B)(6) 2025, CUSTOMER INITIALLY TESTED SID (B)(6) ON WORKLIST (WL) (B)(4) AND RECEIVED A DUAL CT POSITIVE, GC POSITIVE RESULT. PER CUSTOMER LAB POLICY, A SAMPLE IS RETESTED IF THERE IS A DUAL CT POSITIVE, GC POSITIVE RESULT. ON (B)(6) 2025, CUSTOMER RETESTED THE DUAL POSITIVE SID (B)(6) ON WL (B)(4) ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6)) AND RECEIVED A DUAL CT NEGATIVE, GC NEGATIVE RESULT. CUSTOMER CONFIRMED THE DUAL CT NEGATIVE, GC NEGATIVE RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2583159	APTIMA COMBO 2 ASSAY	DNA-REAGENTS, NEISSERIA	LSL	HOLOGIC, INC.		924234

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other