Drugs & medicalClass II

Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

Read the official notice →
Date
2025-07-02
Country
United States
Brand
Siemens Healthcare Diagnostics
Product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2025-08-13
  2. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L.…

    FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  3. 2025-08-06
  4. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

    Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride,…

    FDA · DeviceSiemens Healthcare Diagnostics Incworldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice →
  5. 2025-07-09
  6. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

    Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA,…Official notice →
  7. 2025-06-04
  8. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  9. 2025-05-07
  10. 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; epoc Software…

    The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

    FDA · DeviceSiemens Healthcare Diagnostics IncDomestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia,…Official notice →
  11. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of…

    FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO,…Official notice →
All 80 Siemens Healthcare Diagnostics recalls →

Other drugs & medical recalls in the United States

  1. 2025-07-02
  2. US
    Drugs & medicalClass II

    Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

    The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.

    FDA · DeviceJewel Precision Sheet Metal & Machining Co, Inc.US distribution to Tennessee.Official notice →
  3. US
    Drugs & medicalClass II

    GE Medical Systems China Co., Ltd. recalls GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

    GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz…

    FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution.Official notice →
  4. 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 →
  5. US
    Drugs & medicalClass II

    Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

    The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

    FDA · DeviceJewel Precision Sheet Metal & Machining Co, Inc.US Nationwide distribution in the states of IN, NY, PA.Official notice →
  6. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

    There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

    FDA · DeviceLimacorporate S.p.AWorldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX…Official notice →
  7. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to…

    BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

    FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE,…Official notice →
See all drugs & medical recalls →