MAUDE Adverse Event Report: ABBOTT LABORATORIES Alinity hq Analyzer; Counter, differential cell

Catalog Number	09P68-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed falsely depressed hemoglobin results on the alinity hq processing module for a 62-year-old female.The following results were provided: sid (b)(6), initial hemoglobin result= 51.5 g/l; repeat result= 97.2 g/l there was no impact to patient management reported.

• Brand Name: Alinity hq Analyzer
• Common Device Name: Counter, differential cell
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): Abbott Laboratories; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; +49()6122582960
• MDR Report Key: 25731748
• Report Number: 3016438761-2026-00373
• Device Sequence Number: 10454381
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220031
• 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): 08/03/2026

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: 09P68-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2021
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female