Beckman Coulter Ireland recalls
3 official recalls and safety alerts involving Beckman Coulter Ireland since 2025-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Beckman Coulter Ireland or the relevant agency.
- 2026-01-28
USBeckman 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…
FDA · DeviceBeckman Coulter Ireland, Inc.US: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT,…Official notice →- 2025-12-31
- US
Beckman 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 →