United StatesBECKMAN COULTER BICARBONATE system reagent for quantitative determination of bicarbonate on Beckman Coulter AU analyzers (REF OSR6137, OSR6237, OSR6637, OSR6x37; UDI‑DI codes OSR6137-15099590020187, OSR6237-15099590010348, OSR6637-15099590060206) with listed lot numbers (OSR6137 lots 2681–2690, 2693–2696; OSR6237 lots 2702–2710, 2712–2716; OSR6637 lots 2726, 2728–2730, 2731–2739). The product was recalled because the reagent may generate falsely high bicarbonate results due to interference with lactate dehydrogenase (LDH) in the test sample.
What's being recalled
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Recalling firm: Beckman Coulter Ireland, Inc., O'Callaghan'S Mills, N/A, Ireland.
How to identify it
Catalog Numbers / UDI-DI codes: OSR6137 - 15099590020187 Lot Numbers: 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2693 2694 2695 2696 OSR6237 - 15099590010348 Lot Numbers: 2702 2703 2704 2705 2706 2707 2708 2709 2710 2712 2713 2714 2715 2716 OSR6637 - 15099590060206 Lot Numbers: 2726 2728 2729 2730 2731 2732 2733 2734 2736 2737 2738 2739
The hazard
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guan, 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, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Brazil, Canada, Ecuador, Ireland, Mexico, Netherlands, Panama, Taiwan, and Province of China.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada