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.
Read the official notice →- Date
- 2024-01-31
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
- Classification
- Class II
- Units
- US and Australia, Brazil, Canada, China, France, Germany, Ghana, India,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-03-27
USBeckman 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 → - US
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…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…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%…
- 2023-09-06
- US
Beckman Coulter Inc. recalls Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Lipemic interference failed to meet the performance specification listed within the IFU.
FDA · DeviceBeckman Coulter Inc.US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-31
- US
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- US
KENT IMAGING, INC. recalls Snapshot NIR, REF: KD204
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
FDA · DeviceKENT IMAGING, INC.Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI,…Official notice → - US
Ossur H / F recalls Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may…
FDA · DeviceOssur H / FUS Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA,…Official notice → - US
Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
- US
Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps…
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
FDA · DeviceHologic, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AR,…Official notice → - US
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take…
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA · DeviceSEDECAL SADistribution was made to AL, FL, and NC. There was no military/government…Official notice →