ModerateClass IIOngoing

FDA Devices recall · Reported September 11, 2024

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 11, 2024. Severity: Moderate. Recall number: Z-1546-2024.

Q: Where was the recalled product distributed?

Distribution: Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the Dx…

Recall #: Z-1546-2024
Affected scope: 17 units
Initiated: March 5, 2024

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Beckman Coulter, Inc. recalled DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the qu… - a moderate-severity action.

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the qu… was recalled by Beckman Coulter, Inc. in September 11, 2024. Reason: Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash B…. Check the official notice for the remedy. Verify recall #Z-1546-2024 with the FDA Devices before acting.

The recall

Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash B….

Moderate
severity level: 17 units
affected scope: Class II
classification: September 11, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1546-2024 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

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

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Reason for recall

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1546-2024
Date reported	September 11, 2024
Date initiated	March 5, 2024
Recalling firm	Beckman Coulter, Inc.
Firm location	Chaska, MN
Affected scope	17 units
Distribution	Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

17 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1546-2024) 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.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 11, 2024. Severity: Moderate. Recall number: Z-1546-2024.

Where was the recalled product distributed? ▼

Distribution: Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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.

Semaglutide, 2 mL (2.5mg/mL), Compounded … 2024-09-11 Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL,… 2024-09-11 SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2… 2024-09-11 SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Mul… 2024-09-11

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Vivo 45 LS, pressure and volume ventilato… 2024-09-11 LVP Primary Administration Set, Dual-Inle… 2024-09-11 Trilogy Evo EV300 -- Model Number/ Model… 2024-09-11 Trilogy Evo Universal Ventilator, Model N… 2024-09-11

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported September 11, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026