MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 125 II REAGENT KIT; TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Catalog Number	08P49-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely decreased alinity i ca 125 ii result for a 75-year-old female patient, which was inconsistent with the patient¿s historical results.It is unknown whether the patient has epithelial ovarian cancer.The patient questioned the result, and the sample was repeated, yielding higher results.The following data were provided: sid: (b)(6): on (b)(6) 2026, initial result = 16.8 u/ml (negative).Repeat result = >1000 u/ml.Repeat result (1:10 dilution) = >10,000 u/ml.Historical results: on (b)(6) 2025 result = 8998.0 u/ml (positive).On (b)(6) 2025 result = 4001.0 u/ml (positive).No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending for the alinity i ca 125 ii assay did not identify any related trends.Additionally, a ticket search by lot did not identify an increase in complaint activity for lot 80840fp00.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot 80840fp00 and the complaint issue.The overall performance of the alinity i ca 125 ii reagents was reviewed using field data from customers worldwide.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 80840fp00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for 80840fp00.A review of labeling was performed and found to sufficiently address the customer's issue.Based on the investigation, no systemic issue or deficiency was identified with the alinity i ca 125 ii reagent, lot number 80840fp00.
Event or Problem Description
The customer reported a falsely decreased alinity i ca 125 ii result for a 75 year old female patient, which was inconsistent with the patient¿s historical results.It is unknown whether the patient has epithelial ovarian cancer.The patient questioned the result, and the sample was repeated, yielding higher results.The following data were provided: sid (b)(6): (b)(6) 2026 initial result = 16.8 u/ml (negative).Repeat result = >1000 u/ml.Repeat result (1:10 dilution) = >10,000 u/ml.Historical results: (b)(6) 2025 result = 8998.0 u/ml (positive).(b)(6) 2025 result = 4001.0 u/ml (positive).No impact to patient management was reported.

• Brand Name: ALINITY I CA 125 II REAGENT KIT
• Common Device Name: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24746116
• Report Number: 3002809144-2026-00079
• Device Sequence Number: 9166088
• Product Code: LTK
• UDI-Device Identifier: 00380740131043
• UDI-Public: (01)00380740131043(17)260818(10)80840FP00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Expiration Date: 08/18/2026
• Device Catalogue Number: 08P49-20
• Device Lot Number: 80840FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 75 YR
• Patient Sex: Female