FDA Devices recall · Reported March 26, 2025
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sens…
Beckman Coulter, Inc. recalled Access 2 Immunoassay Analyzer, Catalog Number 81600N - a moderate-severity action.
Access 2 Immunoassay Analyzer, Catalog Number 81600N was recalled by Beckman Coulter, Inc. in March 26, 2025. Reason: Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causi…. Check the official notice for the remedy. Verify recall #Z-1386-2025 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causi….
- Moderate
- severity level
- 873 units
- affected scope
- Class II
- classification
- March 26, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1386-2025 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
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Reason for recall
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1386-2025 |
| Date reported | March 26, 2025 |
| Date initiated | February 5, 2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Chaska, MN |
| Affected scope | 873 units |
| Distribution | Worldwide - US Nationwide distribution. |
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-1386-2025) 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