Drugs & medicalClass II

Beckman Coulter Inc. recalls 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.

Read the official notice →
Date
2025-09-24
Country
United States
Brand
Beckman Coulter
Product
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Classification
Class II
Units
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Beckman Coulter recalls

  1. 2025-10-29
  2. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137

    Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering…

    FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution.Official notice →
  3. 2025-10-15
  4. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

    Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

    FDA · DeviceBeckman Coulter Inc.US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico SingaporeOfficial notice →
  5. 2025-10-08
  6. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i…

    On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress…

    FDA · DeviceBeckman Coulter Inc.Internationally distribution to the countries of Poland, India, Dominican…Official notice →
  7. 2025-08-20
  8. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

    Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or…

    FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy,…Official notice →
  9. 2025-08-13
  10. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

    Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current…

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide.Official notice →
  11. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

    Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL…

    FDA · DeviceBeckman Coulter Inc.US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia,…Official notice →
All 84 Beckman Coulter recalls →

Other drugs & medical recalls in the United States

  1. 2025-09-24
  2. US
    Drugs & medicalClass II

    Abbott Point Of Care Inc. recalls i-STAT EG6+ cartridge. List Number: 03P77-25.

    Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

    FDA · DeviceAbbott Point Of Care Inc.US Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.

    Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

    FDA · DeviceAbbott Point Of Care Inc.US Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Folsom Metal Products, Inc. recalls Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    Labeling includes shelf life that has not been validated.

    FDA · DeviceFolsom Metal Products, Inc.US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Official notice →
  5. US
    Drugs & medicalClass II

    BigTree Sales Inc. recalls The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in…

    The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these…

    FDA · DeviceBigTree Sales Inc.U.S.AOfficial notice →
  6. US
    Drugs & medicalClass II

    Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code:…

    Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

    FDA · DevicePhilips Medical Systems (Cleveland) IncU.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →
  7. US
    Drugs & medicalClass II

    Medical Information Technology, Inc. recalls MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data…

    Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.

    FDA · DeviceMedical Information Technology, Inc.Worldwide distribution - US Nationwide and the countries of British Virgin…Official notice →
See all drugs & medical recalls →