Beckman Coulter Ireland, Inc. recalls The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from…
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to…
Read the official notice →- Date
- 2026-01-28
- Country
- United States
- Brand
- Beckman Coulter Ireland
- Product
- The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL-…
- Classification
- Class II
- Units
- US: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ireland recalls
- 2025-12-31
USBeckman Coulter Ireland, Inc. recalls BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative…
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
FDA · DeviceBeckman Coulter Ireland, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →- 2025-06-04
- US
Beckman Coulter Ireland, Inc. recalls Apo B Reagent, REF: OSR6143
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the…
FDA · DeviceBeckman Coulter Ireland, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice →
Other drugs & medical recalls in the United States
- 2026-01-28
- US
Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal…
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
FDA · DeviceEdan DiagnosticsWorldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT,…Official notice → - US
Community Products, LLC recalls Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or…
Potential for fraying on the body support strap.
FDA · DeviceCommunity Products, LLCWorldwide distribution - US Nationwide and the countries of UAE, Australia,…Official notice → - US
Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions…
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
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Intuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product…
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FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY,…Official notice → - US
MicroPort Orthopedics Inc. recalls Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product…
Due to products not having FDA Premarket authorization to be distributed within the United States.
FDA · DeviceMicroPort Orthopedics Inc.The product was sent to distributors in multiple US states, including Texas,…Official notice → - US
Tyber Medical recalls Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number:…
The supplier manufactured anatomical left plates with an incorrect thread orientation.