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Beckman Coulter DxC 700 AU Chemistry Analyzer
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MEDICAL DEVICE RECALLMODERATE

Beckman Coulter DxC 700 AU Chemistry Analyzer

Beckman Coulter recalls DxC 700 AU and AU5800 analyzers over software delay risk.

What to do

Contact Beckman Coulter service to apply the software solution. Do not leave the calibration monitor open for more than 15 minutes until the fix is installed.

Recalled
Listed
Updated
Recall No.
Z-1553-2026
Agency
FDA
Firm
Beckman Coulter Mishima K.K.
Recall ID
98346
Status
ONGOING

Why it was recalled

Beckman Coulter is recalling DxC 700 AU and AU5800 clinical chemistry analyzers because a software issue may cause a delay in results. When the calibration monitor with Microsoft SQL Server 2022 Express is open beyond 15 minutes, the system may stop analyzing due to database errors, potentially delaying diagnosis and patient treatment.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281Z-1553-202614987666543016, 2025061442, 2025061446, 2025061452, 2025061454, 2025061464, 2025071479, 2025071488, 2025081513, 2025081516, 2025091536, 2025091538, 2025091543, 2025091559, 2025091561, 2025111598, 2025111602, 2025111604, 2025111605, 2025111606
DxC 700 AU, REF: B86444, B86446Z-1552-202614987666542545, 2025060063, 2025060073, 2025060074, 2025060075, 2025060079, 2025060085, 2025060086, 2025060087, 2025060091, 2025060098, 2025060099, 2025060124, 2025060125, 2025060126, 2025060127, 2025060128, 2025060129, 2025070139, 2025070156

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification