Severity
Moderate
ModerateClass IIOngoing
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 FDA Devices action (record #Z-1419-2023) was formally reported on April 26, 2023, with the manufacturer initiating the action on March 15, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter, Inc. is listed as the recalling firm, operating out of Chaska, MN. Federal records list the affected scope as 31,076 units.
The documented reason for this recall is: 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 intro… Distribution data in the federal record shows the product reached: 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…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
31,076 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.. Recalled by Beckman Coulter, Inc.. Units affected: 31,076 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1419-2023.
Where was the recalled product distributed? ▼
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, Taiwan, Thailand, Uruguay, and Viet Nam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1419-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 26, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.