Beckman Coulter, Inc. recalls Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed…
Read the official notice →- Date
- 2024-07-31
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-08-21
USBeckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module.…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of NE, MT, LA, TX, NY,…Official notice →- US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below;…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice → - 2024-07-31
- US
Beckman Coulter Inc. recalls Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2024-07-10
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found…
- US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro…
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of Indiana and the…Official notice → - 2024-04-03
- US
Beckman 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 →
Other drugs & medical recalls in the United States
- 2024-07-31
- US
Securitas Healthcare LLC recalls Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
FDA · DeviceSecuritas Healthcare LLCUS: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NEOfficial notice → - US
Securitas Healthcare LLC recalls Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living…
There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
FDA · DeviceSecuritas Healthcare LLCUS: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and CanadaOfficial notice → - US
Olympus Corporation of the Americas recalls ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of…
Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
- US
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM…
Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Washington Homeopathic Products, Inc. recalls Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic…
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
- US
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and…
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.