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

Catalog Number	08P49-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false depressed alinity i ca 125 ii result for a 70-year-old female patient that has been diagnosed with ovarian cancer.The following results were provided: (lab reference range for ca125 <35 ku/l) (b)(6) 2026 sid (b)(6) initial result = 10 ku/l, (b)(6) 2026 repeat result = 899 ku/l, result after 1:10 dilution = 1008 ku/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity i ca 125 ii reagent kit,08p49-30 to alinity i processing module, 03r65-01.Mdr number 3016438761-2026-00215 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed a false depressed alinity i ca 125 ii result for a 70-year-old female patient that has been diagnosed with ovarian cancer.The following results were provided: (lab reference range for ca125 <35 ku/l) (b)(6) 2026, sid (b)(6) initial result = 10 ku/l, (b)(6) 2026 repeat result = 899 ku/l, result after 1:10 dilution = 1008 ku/l.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: 24647581
• Report Number: 3002809144-2026-00069
• Device Sequence Number: 21311902
• Product Code: LTK
• UDI-Device Identifier: 00380740131050
• UDI-Public: (01)00380740131050(17)260505(10)77693FP00
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 05/05/2026
• Device Catalogue Number: 08P49-30
• Device Lot Number: 77693FP00
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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: 70 YR
• Patient Sex: Female