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	11/26/2025
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.A1 patient identifier: complete list of sample id's are (b)(6).
Event or Problem Description
The customer reported falsely depressed hemoglobin (hgb) results generated on the alinity hq processing module (sn: hq204) and repeated on another alinity hq processing module (sn: (b)(6).The customer reported that they are questioning the following 3 samples for falsely low hemoglobin (hgb) and provided the following data: on (b)(6) 2025, sid (b)(6), initially generated a hemoglobin result of 65 g/l (6.5 g/dl), and repeat another alinity hq processing module was 115 g/l (11.5 g/dl).On (b)(6) 2025, sid (b)(6), initially generated a hemoglobin result of 78.6 g/l (7.86 g/dl), and repeat another alinity hq processing module was 124 g/l (12.4 g/dl).On (b)(6) 2025, sid (b)(6), initially generated a hemoglobin result of 78.9 g/l (7.89 g/dl), and repeat another alinity hq processing module was 130 g/l (13.0 g/dl).There was no impact to patient management reported.
Additional Manufacturer Narrative
The alinity hq analyzer serial number (b)(6) was evaluated and after troubleshooting by field service, the customer reported event was resolve.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did not identify an increase in complaint activity for the alinity hq analyzer with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the alinity hq analyzer as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the alinity hq analyzer serial number (b)(6).
Event or Problem Description
The customer reported falsely depressed hemoglobin (hgb) results generated on the alinity hq processing module (sn: (b)(6) and repeated on another alinity hq processing module (sn: (b)(6).The customer reported that they are questioning the following 3 samples for falsely low hemoglobin (hgb) and provided the following data: on (b)(6) 2025, sid (b)(6), initially generated a hemoglobin result of 65 g/l (6.5 g/dl), and repeat another alinity hq processing module was 115 g/l (11.5 g/dl).On (b)(6) 2025, sid (b)(6), initially generated a hemoglobin result of 78.6 g/l (7.86 g/dl), and repeat another alinity hq processing module was 124 g/l (12.4 g/dl).On (b)(6) 2025, sid (b)(6), initially generated a hemoglobin result of 78.9 g/l (7.89 g/dl), and repeat another alinity hq processing module was 130 g/l (13.0 g/dl).There was no impact to patient management reported.

• Brand Name: ALINITY HQ ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23819249
• Report Number: 2919069-2025-00050
• Device Sequence Number: 13113972
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220031
• 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): 01/16/2026

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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2018
• 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 H HGB REAGENT 975, 07P81-04, UNKNOWN; ALNTY H HGB REAGENT 975, 07P81-04, UNKNOWN
• Patient Sex: Unknown