Beckman Coulter, Inc. recalls DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual…
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Beckman Coulter
- Product
- DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states and territory…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-10-28
Beckman Coulter, Inc. recalls ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…
Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant…
Beckman Coulter, Inc. recalls ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…
Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being…
- 2026-10-14
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521…
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
- 2026-08-26
Beckman Coulter Inc. recalls Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU…
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a…
- 2026-08-12
Beckman Coulter Inc. recalls REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4…
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE,…Official notice →
USOther drugs & medical recalls in the United States
- 2026-10-21
Howmedica Osteonics Corp. recalls TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual…
FDA · DeviceHowmedica Osteonics Corp.These trays are provided by sale or loan. Loans are provided through…Official notice →Cook Incorporated recalls Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part…
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of…
FDA · DeviceCook IncorporatedUS States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain,…Official notice →Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display…
FDA · DeviceMagellan Diagnostics, Inc.US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.Official notice →Microgenics Corporation recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed…
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient…
FDA · DeviceMicrogenics CorporationWorldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX,…Official notice →W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The…
The potential for the devices to be mislabeled with the incorrect length.
FDA · DeviceW L Gore & Associates, Inc.US Nationwide distribution in the states of GA, RI.Official notice →In2bones USA, LLC recalls REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
FDA · DeviceIn2bones USA, LLCUS Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.Official notice →