Drugs & medicalClass II

Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample…

Read the official notice →
Date
2026-05-06
Country
United States
Brand
Siemens Healthcare Diagnostics
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Argentina,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-07-15
  2. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

    The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  3. 2026-06-17
  4. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

    A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  5. 2026-05-06
  6. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

    Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low…

    FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide distribution - US Nationwide and the countries of Italy, Spain,…Official notice →
  7. 2026-04-08
  8. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

    A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Domestic: Nationwide Distribution International: Argentina, Australia,…Official notice →
  9. 2026-03-11
  10. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225

    Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  11. 2025-11-19
  12. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

    The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice →
All 80 Siemens Healthcare Diagnostics recalls →

Other drugs & medical recalls in the United States

  1. 2026-05-06
  2. US
    Drugs & medicalClass II

    DEPUY (IRELAND) recalls Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    FDA · DeviceDEPUY (IRELAND)US Nationwide distribution in the states of MN, NC, TX.Official notice →
  3. US
    Drugs & medicalClass II

    Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium…

    Neutralization Buffer may contain contaminants

    FDA · DeviceImmuno-Mycologics, IncUS Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA,…Official notice →
  4. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

    BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

    FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →
  5. US
    Drugs & medicalClass II

    Philips North America recalls Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE…

    FDA · DevicePhilips North AmericaWorldwide - US Nationwide and the countries of Argentina, Australia,…Official notice →
  6. US
    Drugs & medicalClass II

    Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120;…

    The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

    FDA · DeviceAdvanced Bionics, LLCWorldwide - U.S Nationwide distribution including in the state of AK, AL, AR,…Official notice →
  7. US
    Drugs & medicalClass II

    Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software…

    It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling…

    FDA · DeviceHologic, IncWorldwide distribution - US Nationwide and the countries of Asia Pacific,…Official notice →
See all drugs & medical recalls →