Siemens 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…
Read the official notice →- Date
- 2022-04-06
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The…
- Classification
- Class II
- Units
- Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-05-11
USSiemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN:…
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →- 2022-05-04
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number…
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2022-04-20
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Global Distribution. US Nationwide.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 → - 2021-12-08
- US
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
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution and the countries of DE,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-06
- US
Carefusion 2200 Inc recalls (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion…
The finished device package did not contain the IFU.
FDA · DeviceCarefusion 2200 IncWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
InfuTronix LLC recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and…
An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
- US
Baxter Healthcare Corporation recalls MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Devices distributed lacked regulatory clearance.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of California, Colorado, District of…Official notice → - US
Baxter Healthcare Corporation recalls Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of AK, AZ,…Official notice → - US
Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases…
FDA · DeviceRoche Molecular Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, IL,…Official notice → - US
Mevion Medical Systems, Inc. recalls Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the…
FDA · DeviceMevion Medical Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of FL, MO,…Official notice →