Counter, Differential Cell
FDA adverse event reports and recall history for counter, differential cell (product code GKZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 23,433
- Deaths
- 17
- Injuries
- 319
- Malfunctions
- 22,432
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-11-12Open, ClassifiedSoftware design
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
- 2025-09-17Open, ClassifiedComponent change control
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- 2025-09-17Open, ClassifiedComponent change control
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- 2025-09-17Open, ClassifiedComponent change control
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- 2025-09-17Open, ClassifiedComponent change control
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- 2025-08-01Open, ClassifiedLabeling design
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
- 2025-08-01Open, ClassifiedLabeling design
BD Trucount Controls, 30 Test - REF: 340335
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
- 2025-07-03Open, ClassifiedProcess control
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- 2025-07-03Open, ClassifiedProcess control
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- 2025-04-22Open, ClassifiedSoftware change control
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Monitor counter, differential cell automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.