Exact FDA event identifier

Event 98346

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 30, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Beckman Coulter Mishima K.K.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

DxC 700 AU, REF: B86444, B86446

Z-1552-2026

Recall number: Z-1552-2026
Initiated: January 30, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Beckman Coulter Mishima K.K.
Quantity: 142

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software solution; may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unavailable

No enrichment row joined through the supported exact identifiers. This is missing evidence, not evidence that no root cause exists.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.

device · product 2 of 2

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Z-1553-2026

Recall number: Z-1553-2026
Initiated: January 30, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Beckman Coulter Mishima K.K.
Quantity: 47

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software solution; may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unavailable

No enrichment row joined through the supported exact identifiers. This is missing evidence, not evidence that no root cause exists.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

REF/UDI-DI/ Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B96697/14987666543016/2025061442, 2025061446, 2025061452, 2025061454, 2025061464, 2025071479, 2025071488, 2025081513, 2025081516, 2025091536, 2025091538, 2025091543, 2025091559, 2025091561, 2025111598, 2025111602, 2025111604, 2025111605, 2025111606, 2025121618, 2025121622, 2025121623. B96698/14987666543023/2025061449, 2025061451, 2025061457, 2025061467, 2025071475, 2025071476, 2025071478, 2025071481, 2025071495, 2025071497, 2025081503, 2025081524, 2025091539, 2025091549, 2025091551. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B23279/14987666541296/2014011316, 2014071647, 2014121858, 2014121906. B23280/14987666541302/2016022593. B23281/14987666541319/5094354. B96697/14987666543016/2019074683. B96698/14987666543023/2017063377, 2019114891, 2024101288

Distribution pattern

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.