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Beckman Coulter Mishima K.K.: DxC 700 AU, REF: B86444, B86446

Medical DevicesSource: FDA (device) · Date: 2026-03-18

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Beckman Coulter Mishima K.K.
Product
DxC 700 AU, REF: B86444, B86446
Reason / hazard
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.
Recall initiated
2026-01-30
Code info
REF/UDI-DI/Serial Numbers: Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B86444/14987666542545/2025060063, 2025060073, 2025060074, 2025060075, 2025060079, 2025060085, 2025060086, 2025060087, 2025060091, 2025060098, 2025060099, 2025060124, 2025060125, 2025060126, 2025060127, 2025060128, 2025060129, 2025070139, 2025070156, 2025070159, 2025070160, 2025070161, 2025070164, 2025070167, 2025070168, 2025070169, 2025070178, 2025070180, 2025070181, 2025070182, 2025070184, 2025070186, 2025070191, 2025070192, 2025070193, 2025070194, 2025070204, 2025080208, 2025080217, 2025080219, 2025080236, 2025080237, 2025080238, 2025080241, 2025080242, 2025080246, 2025080247, 2025080250, 2025090266, 2025090267, 2025090270, 2025090271, 2025090273, 2025090274, 2025090275, 2025090281, 2025090283, 2025090285, 2025090286, 2025090287, 2025090289, 2025090290, 2025090291, 2025090292, 2025090293, 2025090294, 2025090295, 2025090296, 2025090297, 2025090298, 2025090299, 2025090301, 2025090302, 2025090303, 2025090304, 2025090306, 2025100370, 2025100371, 2025100372, 2025100373, 2025100421, 2025100422, 2025100423, 2025100424, 2025100425, 2025100426, 2025100427, 2025110428, 2025110429, 2025110437, 2025110442, 2025110445, 2025110452, 2025110454, 2025110456, 2025110457, 2025110458, 2025110462, 2025120464, 2025120468, 2025120469, 2025120471, 2025120475, 2025120477, 2025120478, 2025120479, 2025120480, 2025120482, 2025120483, 2025120484, 2025120485, 2025120486, 2025120487, 2025120488, 2025120489, 2025120490, 2025120492, 2025120493, 2025120494, 2025120495, 2025120496. B86446/14987666542514/2025090277, 2025090284. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B86444/14987666542545/2017050064, 2017100174, 2018030312, 2018040352, 2018100561, 2018110599, 2019010712, 2019010713, 2019111170, 2021021852, 2021102318, 2021122458, 2022042631, 2022052705, 2022062775, 2023063701, 2024064408, 2024064419, 2024064440
Product quantity
142
Voluntary mandated
Voluntary: Firm initiated
City
Sunto-Gun
State
N/A
Country
Japan
Event id
98346
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