Z-1419-2023Class II

Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs

Name: Z-1419-2023 Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs
Creator: Beckman Coulter, Inc.
Published: 2023-03-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-03-15 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs on 2023-03-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1419-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-15
Posted: 2023-04-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recalling firm issued letters dated 3/8/2023 via mail and email. The letter described the issue, impact, and actions to be taken. The actions included discontinuing use of the affected lot and discard all remaining reagent packs from this lot. The letter is to be shared with the consignee laboratory and/or medical director regarding the need to review previous patient test results. The consignee is to contact their local Beckman Coulter representative for replacement product requests. If the product has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. A response was requested within 10 days via email or completion and return of the enclosed response form. The response form is to indicate the letter has been read and understood and all relevant personnel have been informed of its contents. The consignee is also to indicate whether or not they had the affected product.
Quantity in commerce: 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, Taiwan, Thailand, Uruguay, and Viet Nam.
Product codes and lots: Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1419-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1419-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-20

Product code CDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)