CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report
DxC 700 AU recalled by Beckman Coulter Mishima K.K
Beckman Coulter Mishima K.K is recalling DxC 700 AU, distributed nationwide in the US. The recall was initiated on 30 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1552-2026
- FDA event ID
- 98346
- Recalling firm
- Beckman Coulter Mishima K.K, Sunto-Gun, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2026
- FDA classified
- 11 Mar 2026
- Reported
- 18 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Jan 2026 | Recall initiated by company | |
| 11 Mar 2026 | Classified by FDA | +40 days |
| 18 Mar 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DxC 700 AU, REF: B86444, B86446
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutFloridaGeorgiaHawaiiIdahoIllinoisKansasLouisianaMarylandMaineMichiganMinnesotaMissouriMississippiMontanaNorth Carolina
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98346This product is part of a recall event; the main page for the event is Chemistry Analyzer Au5800 recalled by Beckman Coulter Mishima K.K.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Chemistry Analyzer Au5800 recalled by Beckman Coulter Mishima K.K | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
More recalls from Beckman Coulter Mishima K.K
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Analyzer Au5800 recalled by Beckman Coulter Mishima K.K | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Sample probe sucks a sample dispensed into a tube or cup recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Sample probe sucks a sample dispensed into a tube or cup recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzer recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzer recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
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