Beckman Coulter Ireland recalls
Beckman Coulter Ireland appears in 3 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 3 |
|---|---|
| Published | 2025-06-04 to 2026-01-28 |
| By agency | FDA Device (3) |
| By classification | Class II (2), Class III (1) |
| By status | ongoing (3) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- The LDL-Cholesterol assay is comprised of two distinct phases
FDA Device · Class II · 2026-01-28 · Beckman Coulter Ireland
Reason: 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 triglyceri… - BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bica…
FDA Device · Class II · 2025-12-31 · Beckman Coulter Ireland
Reason: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. - Apo B Reagent, REF: OSR6143
FDA Device · Class III · 2025-06-04 · Beckman Coulter Ireland
Reason: 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 tota…