MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN RUBY; COUNTER, DIFFERENTIAL CELL

Catalog Number	08H67-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed imprecise hemoglobin results on a cell-dyn ruby analyzer for one sample.The following results were provided: rep 1 hgb = 8.38.Rep 2 hgb = 12.7.Rep 3 hgb = 5.94.Rep 4 hgb = 8.25 rep 5 hgb = 7.98.The sample was repeated on another instrument generating a hgb result of 13.6.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.
Additional Manufacturer Narrative
Service inspected the instrument and replaced and calibrated the y valve assy, pre-aligned with flag and wheel, which resolved the issue.Review of the instrument service history found no subsequent complaints for imprecise hemoglobin patient results.Ticket trending review for the y valve assy, pre-aligned with flag and wheel did not identify any trends.Device history review did not identify any non-conformances or potential non-conformances related to the complaint issue.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the cell-dyn ruby, serial number (b)(6).
Event or Problem Description
The customer observed imprecise hemoglobin results on a cell-dyn ruby analyzer for one sample.The following results were provided: rep 1 hgb = 8.38.Rep 2 hgb = 12.7.Rep 3 hgb = 5.94.Rep 4 hgb = 8.25.Rep 5 hgb = 7.98 the sample was repeated on another instrument generating a hgb result of 13.6 there was no impact to patient management.

• Brand Name: CELL-DYN RUBY
• 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: 24605232
• Report Number: 2919069-2026-00003
• Device Sequence Number: 13004732
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K061667
• 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): 03/26/2026

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: 08H67-01
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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: Unknown