Beckman Coulter, Inc. recalls Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive…
Read the official notice →- Date
- 2024-02-14
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2024-04-03
USBeckman Coulter, Inc. recalls Access Substrate, REF 81906, For use with the Access Immunoassay Systems
On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman…
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice →- 2024-03-27
- US
Beckman Coulter, Inc. recalls Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - 2024-02-14
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2)…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-01-31
- US
Beckman Coulter, Inc. recalls Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
FDA · DeviceBeckman Coulter, Inc.US and Australia, Brazil, Canada, China, France, Germany, Ghana, India,…Official notice → - 2023-10-18
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of Florida, and the…Official notice → - US
Beckman Coulter, Inc. recalls Access Thyroglobulin Calibrators
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11%…
Other drugs & medical recalls in the United States
- 2024-02-14
- US
CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard,…
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
- US
Steris Corporation recalls Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN,…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2)…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Barco N.V. recalls Barco MDSC-8527 NXF, Part Number K9352421
Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.
- US
Maquet Medical Systems USA recalls BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or…
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms:…
FDA · DeviceMaquet Medical Systems USAWorldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC,…Official notice → - US
G & H Wire Company recalls FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
FDA · DeviceG & H Wire CompanyWorldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and…Official notice →