Drugs & medicalClass II

Beckman Coulter, Inc. recalls MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

Read the official notice →
Date
2022-11-30
Country
United States
Brand
Beckman Coulter
Product
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Classification
Class II
Units
Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2023-04-26
  2. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

    The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This…

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice →
  3. 2023-03-22
  4. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access…

    An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay…

    FDA · DeviceBeckman Coulter, Inc.Worldwide and Nationwide Distribution. There was government/military…Official notice →
  5. 2023-01-11
  6. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN…

    FDA · DeviceBeckman Coulter, Inc.US and Canada, Brazil, Korea, Mexico, Puerto Rico, TaiwanOfficial notice →
  7. 2022-05-25
  8. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls MicroScan WalkAway-40 plus Instrument REF B1018-283

    WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

    FDA · DeviceBeckman Coulter Inc.Worldwide distribution - U.S. Nationwide distribution in the states of Alaska,…Official notice →
  9. 2022-04-27
  10. US
    Drugs & medicalClass III

    Beckman Coulter, Inc. recalls Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    IRISpec CA failures for glucose.

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice →
  11. 2022-03-09
  12. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

    Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is…

    FDA · DeviceBeckman Coulter Inc.US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,…Official notice →
All 84 Beckman Coulter recalls →

Other drugs & medical recalls in the United States

  1. 2022-11-30
  2. US
    Drugs & medicalClass II

    Smiths Medical ASD Inc. recalls Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming…

    Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

    FDA · DeviceSmiths Medical ASD Inc.US distribution to states of: Indiana, Texas and VirginiaOfficial notice →
  3. US
    Drugs & medicalClass II

    Kamiya Biomedical Company, LLC recalls K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    IgA Reagent may start showing cloudiness over time, which can affect assay performance.

    FDA · DeviceKamiya Biomedical Company, LLCWorldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA,…Official notice →
  4. US
    Drugs & medicalClass II

    Endo-Therapeutics, Inc. recalls eSuction Small Cavity, Model ET2005

    Improper device regulatory classification

    FDA · DeviceEndo-Therapeutics, Inc.US distribution to Florida and PennsylvaniaOfficial notice →
  5. US
    Drugs & medicalClass II

    Abbott Molecular, Inc. recalls Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

    Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and…

    FDA · DeviceAbbott Molecular, Inc.Worldwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Hamilton Medical AG recalls Hamilton-C6

    Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.

    FDA · DeviceHamilton Medical AGU.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN,…Official notice →
  7. US
    Drugs & medicalClass II

    Allison Medical, Inc. recalls InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC

    Insulin syringe retail packages incorrectly labeled as "Short Needle".

    FDA · DeviceAllison Medical, Inc.TexasOfficial notice →
See all drugs & medical recalls →