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	04/27/2026
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed wbc, hemoglobin and neutrophil results on three patients when processed on the alinity hq analyzer.The following data was provided.On (b)(6) 2026, sid (b)(6), male, born in 1967; wbc= initial result 4.89 & repeat results =15.0 10e3/l, repeat results on another analyzer (b)(6) = 14.7 10e3/l.Initial hemoglobin results were 7.59, 15.0 g/dl & repeat results on another analyzer (b)(6) = 14.6 g/dl, neutrophil= initial results 4.15 & repeat results =12.2 10e3/l, repeat results on another analyzer (b)(6) 12.0 10e3/l, rbc= 2.82, 5.29 10e6/l repeat results on another analyzer (b)(6) 5.22 10e6/l.On (b)(6) 2026, sid (b)(6) male, born in 1969; wbc = initial result 2.41 & repeat result 6.06 10e3/l, rbc (initial, repeat) = 4.94,2.92 10e6/, hemoglobin (initial, repeat) =15.1,8.3 g/dl.On (b)(6) 2026, sid (b)(6), male- born in 1938, wbc= initial result 2.99 & repeat result 6.39 10e3/l, hemoglobin = initial result = 7.04, repeat result 11.9 g/dl, rbc (initial, repeat) = 2.89,3.94 10e6/l.No impact to patient management was 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 ; 6122582960
• MDR Report Key: 25110700
• Report Number: 3016438761-2026-00258
• Device Sequence Number: 10339290
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/12/2026

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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown