The Recall Desk
HighFDA (Devices)·Z-1529-2025·Announced 2025-04-16

Beckman Coulter DxI 9000 Immunoassay Analyzer Electrical Short Risk

Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzer units due to ground screws on PCB boards that may cause electrical shorts, leading to smoke and delayed patient test 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: This is an FDA Class II medical device recall. The hazard involves potential electrical shorts leading to smoke, which poses a risk of harm to equipment and users; however, no illnesses or injuries are reported in the source text, keeping it within the High category per the rubric.

Plain-English summary

Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer, catalog number C11137, an in vitro diagnostic device used to measure various substances in human body fluids. The recall affects 30 units distributed outside the United States to Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and the United Kingdom.

Ground screws on PCB boards in affected units may cause electrical shorts. This hazard can lead to smoke generation, which poses a risk to equipment and users. Smoke from these shorts may also delay patient test results.

The affected lot/serial numbers are: 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, and 300156 (UDI-DI 15099590732103).

Users of affected devices should contact Beckman Coulter, Inc. for further instructions regarding the recall.

The recalled product

Product
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Diagnostic Equipment
Hazard
Affected units
30

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)

  • UDI-DI 15099590732103 Serial/Lot Numbers: 300116
  • 300117
  • 300118
  • 300123
  • 300126
  • 300128
  • 300129
  • 300130
  • 300131
  • 300133
  • 300134
  • 300135
  • 300136
  • 300137
  • 300138
  • 300139
  • 300141
  • 300142
  • 300143
  • 300145

Distribution

Distribution scope not specified by the agency.

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