MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HBC REAGENT KIT; TEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)

Catalog Number	07P84-21
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false negative alinity i anti-hbc results.On (b)(6) 2026, sid (b)(6) (male, 69 years old) was 0.95 s/co grayzone, repeated 0.30 s/co nonreactive, 0.23 s/co nonreactive, 0.23 s/co nonreactive.The same sample was repeated on serial (b)(6) with the same reagent lot 76110be00.On (b)(6) 2026 result was 1.65 s/co reactive, 1.44 s/co reactive, 1.51 s/co reactive.It is unknown what result was reported out of lab.Reference lab result came back as nonreactive.Additionally, the customer pulled samples that already resulted from this instrument and ran them on serial (b)(6), with different results from 2 samples.On (b)(6) 2026, sid (b)(6) was 2.58 s/co reactive, repeat 0.69 nonreactive, 2nd repeat 4.87 reactive.Sid (b)(6) was reported as reactive, but on (b)(6) 2026 repeated on serial (b)(6) result of 0.22 s/co nonreactive.On (b)(6) 2026, sid (b)(6) was 1.43, 1.99 s/co reactive.Sid (b)(6) was reported as reactive but on (b)(6) 2026 repeated on serial (b)(6) result of 0.74 s/co nonreactive.Normal reference range of <0.80 s/co nonreactive, grayzone of 0.80 to <1.21 s/co, reactive of = 1.21 s/co.No additional patient information was provided.No impact to patient management was reported.

• Brand Name: ALINITY I ANTI-HBC REAGENT KIT
• Common Device Name: TEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)
• 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: 24772037
• Report Number: 3002809144-2026-00084
• Device Sequence Number: 10157093
• Product Code: LOM
• UDI-Device Identifier: 00380740136659
• UDI-Public: (01)00380740136659(17)260509(10)76110BE00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 05/09/2026
• Device Catalogue Number: 07P84-21
• Device Lot Number: 76110BE00
• 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: 06/03/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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)
• Patient Sex: Unknown