Class IIReported 2026-03-18

DxC 700 AU, REF: B86444, B86446

Recalled by Beckman Coulter Mishima K.K.

Reason for Recall

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.

Recall Number

Z-1552-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-30

Reported

2026-03-18

Distribution

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.

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.