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.
What this means for you
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.
- Hazard
- software-defect
- system-halt
- treatment-delay
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.
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