Z-1303-2024Class II

Access Total T4, REF 33800, IVD, thyroxine reagent assay

Name: Z-1303-2024 Access Total T4, REF 33800, IVD, thyroxine reagent assay
Creator: Beckman Coulter, Inc.
Published: 2024-02-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-02-08 / Open, Classified / root cause: supplier

FDA source

Beckman Coulter, Inc. began a recall of Access Total T4, REF 33800, IVD, thyroxine reagent assay on 2024-02-08. FDA classified it as Class II and gives the reason as "Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1303-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-08
Posted: 2024-03-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The recalling firm issued letters on 2/8/2024 via email and standard postal mail to their U.S. customers and postal mail to their OUS customers. The letter explained the issue, impact, and actions to be taken. The actions included: (1) Discontinue using the affected lots and discard all remaining reagent packs from the lots; (2) The firm recommended performing a retrospective review on patient results generated with the affected reagent lots and assess the need for retesting;(3) Contact the local Beckman Coulter representative for replacement product requests; (4) For customers in the U.S. and Canada, complete the attached Replacement Order Form; and (5) For customers outside the U.S. and Canada, contact their local Beckman Coulter representative. The consignee was requested to share the letter information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If the affected product was forwarded to another laboratory, they were requested to provide them a copy of the letter. The consignee was requested to respond within 10 days either electronically via email or manually by completing and returning the enclosed Response Form.
Quantity in commerce: 64,009 kits
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.
Product codes and lots: Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1303-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1303-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-15

Product code KLI

K023369Class IIAccess Total T4 AssayBeckman Coulter, Inc. / cleared 2002-12-09

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)