FDA Devices recall · Reported April 26, 2023
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results …
Beckman Coulter, Inc. recalled Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contain… - a moderate-severity action.
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contain… was recalled by Beckman Coulter, Inc. in April 26, 2023. Reason: The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not co…. Check the official notice for the remedy. Verify recall #Z-1419-2023 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not co….
- Moderate
- severity level
- 31K units
- affected scope
- Class II
- classification
- April 26, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1419-2023 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 Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Reason for recall
The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1419-2023 |
| Date reported | April 26, 2023 |
| Date initiated | March 15, 2023 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Chaska, MN |
| Affected scope | 31,076 units |
| Distribution | Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Brazil, Canada, China, Costa Rica, El Salvador, Georgia, Hong Kong, Malaysia, Mexico, Myanmar, New Zealand, Peru, Philippines, Qatar, Singapore, … |
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-1419-2023) 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