Drugs & medicalClass II

Siemens Healthcare Diagnostics, Inc. recalls DCA Systems HbA1c Reagent Kit

The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be…

Read the official notice →
Date
2024-03-27
Country
United States
Brand
Siemens Healthcare Diagnostics
Product
DCA Systems HbA1c Reagent Kit
Classification
Class II
Units
Worldwide distribution - US Nationwide and the country of Taiwan.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Siemens Healthcare Diagnostics recalls

  1. 2024-07-03
  2. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas…

    Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software…

    FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and…Official notice →
  3. 2024-05-29
  4. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.

    The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, CA, DC,…Official notice →
  5. 2024-04-24
  6. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium…

    Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  7. 2024-03-20
  8. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Erythropoietin (EPO) Assay (100 Test)

    Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI,…Official notice →
  9. 2024-02-14
  10. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

    Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
  11. 2023-12-27
  12. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to…

    RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of…

    FDA · DeviceSiemens Healthcare Diagnostics IncNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina…Official notice →
All 80 Siemens Healthcare Diagnostics recalls →

Other drugs & medical recalls in the United States

  1. 2024-03-27
  2. US
    Drugs & medicalClass II

    Mc3 Inc recalls NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon…

    May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced…

    FDA · DeviceMc3 IncUS Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Sarnova HC, Llc recalls Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number:…

    Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

    FDA · DeviceSarnova HC, LlcUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Natus Neurology Inc recalls TENSIVE Conductive Adhesive Gel, REF 016-401600

    Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five…

    FDA · DeviceNatus Neurology IncWorldwide distribution - US Nationwide and the country of Canada.Official notice →
  5. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Access Total T4, REF 33800, IVD, thyroxine reagent assay.

    Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice →
  6. US
    Drugs & medicalClass I

    Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption…

    Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

    FDA · DeviceThoratec Corp.Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice →
  7. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This…

    FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution: US (nationwide) and OUS countries of: Algeria,…Official notice →
See all drugs & medical recalls →