Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting,…
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Read the official notice →- Date
- 2021-12-08
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution and the countries of DE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-04-06
USSiemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension…
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ,…Official notice →- 2022-01-12
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to…
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE…Official notice → - 2022-01-05
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of…
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - 2021-11-10
- US
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
FDA · DeviceSiemens Healthcare Diagnostics, IncUS Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1…
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical…
- 2021-11-03
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Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution.Official notice →
Other drugs & medical recalls in the United States
- 2021-12-15
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Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
- 2021-12-08
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GE Healthcare, LLC recalls GE Centricity Universal Viewer Zero Footprint Client
There is a potential to display incomplete patient imaging study.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - US
Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.Official notice → - US
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