Agency classClass IIOur severity:High FDA (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.

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: 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: electrical-short
fire
smoke
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.

Same manufacturer · Beckman Coulter, Inc.

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Same hazard · electrical short