MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT; RADIOASSAY, VITAMIN B12

Catalog Number	09P26-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity i active b12 result generated on an alinity i processing module for one patient sample.Sid (b)(6) result on lot 12569up00 = 29.7 pmol/l, result on other lot = 18.1 pmol/l.There was no impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Continued information for section e1 phone number: (b)(6).

• Brand Name: ALINITY I ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
• Common Device Name: RADIOASSAY, VITAMIN B12
• 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: 25136873
• Report Number: 3002809144-2026-00121
• Device Sequence Number: 9454429
• Product Code: CDD
• UDI-Device Identifier: 00380740189815
• UDI-Public: (01)00380740189815(17)270105(10)12569UP00
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112443
• 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): 06/15/2026

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 Catalogue Number: 09P26-35
• Device Lot Number: 12569UP00
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2026
• 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 Age: 30 YR
• Patient Sex: Female