Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro…
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four…
Read the official notice →- Date
- 2024-09-25
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with…
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Beckman Coulter, Inc. recalls Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative,…
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator…
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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative…
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking,…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of New Hampshire and the…Official notice → - 2024-09-04
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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS,…Official notice → - 2024-08-21
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Beckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
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Cypress Medical Products LLC recalls BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
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Safeguard US Operating LLC recalls HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Incorrect expiration date.
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B Braun Medical Inc recalls SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.…
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient…
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