FDA Devices recall · Reported July 10, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fitting…
Beckman Coulter, Inc. recalled Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry … - a moderate-severity action.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry … was recalled by Beckman Coulter, Inc. in July 10, 2024. Reason: The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable …. Check the official notice for the remedy. Verify recall #Z-2237-2024 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable ….
- Moderate
- severity level
- Class II
- classification
- July 10, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2237-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
Reason for recall
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2237-2024 |
| Date reported | July 10, 2024 |
| Date initiated | February 29, 2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Chaska, MN |
| Affected scope | 9 instruments |
| Distribution | Worldwide - US Nationwide distribution in the state of Indiana and the countries of Italy, Sweden, Ireland, Spain. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2237-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026