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…
Read the official notice →- Date
- 2024-04-24
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2024-09-18
USSiemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL,…Official notice →- 2024-07-03
- US
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 → - 2024-05-29
- US
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 → - 2024-03-27
- US
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…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the country of Taiwan.Official notice → - 2024-03-20
- US
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 → - 2024-02-14
- US
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 →
Other drugs & medical recalls in the United States
- 2024-04-24
- US
ACTIM OY recalls Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.
- US
Conformis, Inc. recalls Identity Imprint PS Tibial Tray Size 4: Lot 540287
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of FL, KS and NH.Official notice → - US
Philips North America Llc recalls Ingenia 1.5T S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Artivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- US
Unomedical A/S recalls Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for…
- US
Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e)…
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead…