The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1552-2026·Announced 2026-03-18

Beckman Coulter DxC 700 AU analyzer may stop analyzing after errors

Beckman Coulter is recalling DxC 700 AU analyzers because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states the fault may delay diagnosis and patient treatment, and no injuries are stated.

Plain-English summary

Beckman Coulter Mishima K.K. is recalling the DxC 700 AU, REF B86444 and B86446. About 142 units were distributed across 36 US states and Puerto Rico. The FDA has classified this recall as Class II.

A delay in results may occur. When the clinical chemistry analyzer calibration monitor, on a PC installed with Microsoft SQL Server 2022 Express, is open beyond 15 minutes it may lead to reagent blank and calibration databases not opening, producing "CAL History DB Open Error" and "RB History DB Open Error" messages. The system will stop analyzing and a firm service visit is required to apply a software solution, which may lead to delay in diagnosis and/or patient treatment.

Affected instruments are listed by REF, UDI-DI and serial number in the FDA enforcement record.

Laboratories can identify affected analyzers by the REF numbers above, and may contact Beckman Coulter Mishima K.K. for further information.

The recalled product

Product
DxC 700 AU, REF: B86444, B86446
Manufacturer
Beckman Coulter Mishima K.K.
Category
Medical Device — Clinical analyzer
Hazard
Affected units
142

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 2025060073
  • 2025060074
  • 2025060075
  • 2025060079
  • 2025060085
  • 2025060086
  • 2025060087
  • 2025060091
  • 2025060098
  • 2025060099
  • 2025060124
  • 2025060125
  • 2025060126
  • 2025060127
  • 2025060128
  • 2025060129
  • 2025070139
  • 2025070156
  • 2025070159
  • 2025070160

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Mishima K.K. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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