Drugs & medicalClass II

Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a…

Read the official notice →
Date
2025-07-23
Country
United States
Brand
Beckman Coulter
Product
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Classification
Class II
Units
International distribution to the country of Andorra, Bulgaria, Denmark,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2025-08-13
  2. 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 →
  3. 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 →
  4. 2025-07-30
  5. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

    A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing…

    FDA · DeviceBeckman Coulter Inc.US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany,…Official notice →
  6. 2025-07-02
  7. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412;…

    Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may…

    FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR,…Official notice →
  8. US
    Drugs & medicalClass II

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

    Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as…

    FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI,…Official notice →
  9. 2025-06-18
  10. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

    A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the…

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries…Official notice →
All 84 Beckman Coulter recalls →

Other drugs & medical recalls in the United States

  1. 2025-07-23
  2. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806…

    Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution;…

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD,…Official notice →
  3. US
    Drugs & medicalClass II

    Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description:…

    Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

    FDA · DeviceWaismed Ltd.Worldwide distribution: US (nationwide) to state of: NC and OUS…Official notice →
  4. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

    Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which…

    FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…Official notice →
  5. US
    Drugs & medicalClass II

    NeuroSync, Inc. recalls NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android…

    Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.

    FDA · DeviceNeuroSync, Inc.United States Nationwide distribution in the states of New York (NY), Texas…Official notice →
  6. US
    Drugs & medicalClass II

    Beyond Laser Systems, LLC recalls Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.

    The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not…

    FDA · DeviceBeyond Laser Systems, LLCUS Nationwide DistributionOfficial notice →
  7. US
    Drugs & medicalClass I

    Intersurgical Inc recalls i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

    Potential for faulty devices as a result of depleted batteries.

    FDA · DeviceIntersurgical IncUS distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC,…Official notice →
See all drugs & medical recalls →