Reported Mar 18, 2026 · Ongoing
DxC 700 AU, REF: B86444, B86446
Beckman Coulter Mishima K.K.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Mishima K.K. · 454-32 · Sunto-Gun, N/A · N/A
Is this the product you have?
- DxC 700 AU
- REF
B86444B86446
- Lot codes and dates
- REF/UDI-DI/Serial NumbersNewer Instrument Installed with PC preinstalled
- with Microsoft SQL Server 2022 ExpressB86444/14987666542545/2025060063, 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
B86444/14987666542545/2017050064201710017420180303122018040352201810056120181105992019010712201901071320191111702021021852202110231820211224582022042631202205270520220627752023063701202406440820240644192024064440
- Amount recalled
- 142
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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