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	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed hemoglobin on the alinity hq processing module for one female patient.The following results were provided: (b)(6) 2026, sid (b)(6), initial hemoglobin results= 78 g/l, 76 g/l; repeat result on a recollected sample= 84 g/l; result from (b)(6) 2026= 84 g/l (reference range 120 to 160 g/l).There was no impact to patient management reported.
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.

• 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: 50803010
• Report Number: 3016438761-2026-00516
• Device Sequence Number: 10589715
• 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): 09/29/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Female