Z-1922-2026Class II

Access Total T4 Calibrator, Catalog No. 33805

Name: Z-1922-2026 Access Total T4 Calibrator, Catalog No. 33805
Creator: Beckman Coulter, Inc.
Published: 2026-03-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-03-16 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access Total T4 Calibrator, Catalog No. 33805 on 2026-03-16. FDA classified it as Class II and gives the reason as "Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a...". 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-1922-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-16
Posted: 2026-04-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Total T4 Calibrator, Catalog No. 33805
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Pending
Quantity in commerce: 2068 US, 2830 OUS
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen.
Product codes and lots: UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1922-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1922-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

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)