Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to…
Read the official notice →- Date
- 2024-09-18
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
- Classification
- Class II
- Units
- Domestic: Nationwide Distribution. International: Austria, Belgium, Canada,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-09
USSiemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice →- 2024-09-25
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human…
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH,…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-09-18
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distributionOfficial notice → - US
Siemens 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 →
Other drugs & medical recalls in the United States
- 2024-09-18
- US
Medtronic Neuromodulation recalls Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset…
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls CRANIOTOMY PACK, Pack Number DYNJ46552O
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes…
- US
Ultradent Products, Inc. recalls Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A…
Due to a manufacturing issue, red particulates present in the expressed composite.
FDA · DeviceUltradent Products, Inc.US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND,…Official notice → - US
Siemens 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.
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Bard Peripheral Vascular Inc recalls Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen…
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur…
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MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.