Drugs & medicalClass II

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and…

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Read the official notice →
Date
2023-03-01
Country
United States
Brand
Siemens Healthcare Diagnostics
Product
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood…
Classification
Class II
Units
Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2023-05-10
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    Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number…

    There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice →
  3. 2023-03-22
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    Siemens Healthcare Diagnostics, Inc. recalls Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus…

    Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile…Official notice →
  5. 2023-03-15
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    Siemens Healthcare Diagnostics Inc recalls epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2,…

    pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

    FDA · DeviceSiemens Healthcare Diagnostics IncNationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus…Official notice →
  7. 2023-03-01
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    Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection…

    Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide distribution in the states of GA, UT.Official notice →
  9. 2023-01-18
  10. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/…

    Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice →
  11. 2022-12-21
  12. US
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    Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the…

    Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿…Official notice →
All 80 Siemens Healthcare Diagnostics recalls →

Other drugs & medical recalls in the United States

  1. 2023-03-01
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    Cardinal Health 200, LLC recalls Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A

    Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

    FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of GA, PA.Official notice →
  3. US
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    Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for…

    Label with the incorrect component listed on the inner kit Tyvek header bag

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    Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for…

    Product Mislabeled on the outer bag and inner kit Tyvek header bag

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    Hologic, Inc. recalls Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D…

    C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

    FDA · DeviceHologic, Inc.US Nationwide distribution.Official notice →
  6. US
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    Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection…

    Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide distribution in the states of GA, UT.Official notice →
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    Draeger Medical, Inc. recalls NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

    The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

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See all drugs & medical recalls →