The Recall Desk
HighFDA (Devices)·Z-2145-2023·Announced 2023-07-26

Beckman Coulter DxA Automation System software defect may cause incorrect test results

Beckman Coulter DxA Automation Systems contain a software defect that may cause tests to run on incompatible sample tube types, potentially producing erroneous patient results.

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: FDA Class II recall for a software defect with potential to cause erroneous patient results. No illnesses, injuries, or deaths have been reported. Per the rubric, this qualifies as High severity because it represents a risk-of-harm product where actual injury has not yet been reported.

Plain-English summary

Beckman Coulter Biomedical GmbH is recalling the DxA Automation System (model DxA 5000 Fit, REF: B87352) due to a software defect affecting all serial numbers. This automated laboratory testing system is used in clinical diagnostic settings.

The defect may cause the system to run tests on patient samples using tube types that are not compatible with the requested test type. This incompatibility could result in erroneous test results, potentially affecting clinical decision-making.

The recall affects 15 units distributed across 19 U.S. states (AL, CA, FL, IL, IN, KY, MI, MN, MO, NE, NJ, NV, NY, OH, PA, SC, TX, WI, WV) and multiple international locations including Australia, Belgium, Canada, China, France, Germany, Italy, Korea, Netherlands, Spain, Switzerland, and the United Kingdom. The affected product is identified by UDI-DI (01)15099590707118.

Healthcare facilities currently using the DxA Automation System should contact Beckman Coulter Biomedical GmbH immediately for guidance on remediation. Test results generated during the period of uncertainty regarding this defect should be reviewed for potential impact on patient care.

The recalled product

Product
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Manufacturer
Beckman Coulter Biomedical GmbH
Category
Medical Device — Automated Laboratory System
Hazard
  • software-defect
  • erroneous-patient-results
  • sample-type-mismatch

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 (2)

  • UDI-DI: (01)15099590707118
  • All DxA serial numbers

Distribution

Distributed in 19 states:

  • AL
  • CA
  • FL
  • IL
  • IN
  • KY
  • MI
  • MN
  • MO
  • NE
  • NJ
  • NV
  • NY
  • OH
  • PA
  • SC
  • TX
  • WI
  • WV

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