Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally…
Read the official notice →- Date
- 2025-11-12
- Country
- United States
- Brand
- Beckman Coulter
- Product
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-01-14
USBeckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs,…
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice →- 2025-12-17
- US
Beckman Coulter, Inc. recalls Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the…
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could…
- 2025-11-26
- US
Beckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro…
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY,…Official notice → - 2025-11-12
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Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading…
- 2025-11-05
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Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and…
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters,…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN,…Official notice → - 2025-10-29
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137
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Other drugs & medical recalls in the United States
- 2025-11-19
- US
Medline Industries, LP recalls Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic…
FDA · DeviceMedline Industries, LPInternational distribution to Mexico and Panama. US nationwide distribution to…Official notice → - US
Cerenovus Inc recalls CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4…
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
FDA · DeviceCerenovus IncUS Nationwide distribution: CO, GA, MD, UT, OK, WI, MA, TN, SC, TX, CA, WV,…Official notice → - US
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There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting…
FDA · DeviceSiemens Medical Solutions USA, IncUS distribution to California. International distribution to Australia,…Official notice → - 2025-11-12
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Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic…
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