Z-0094-2025Class II

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative...

Name: Z-0094-2025 The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative...
Creator: Beckman Coulter, Inc.
Published: 2024-08-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-08-28 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone... on 2024-08-28. FDA classified it as Class II and gives the reason as "Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0094-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-28
Posted: 2024-10-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via US mail and email. The notice explained the problem, potential impact, requested the discontinuation of use and destruction of the affected product. The notice should be shared with all impacted parties and a retrospective review of patient tests is recommended. For questions regarding this notice, please contact Customer Support Center: . From our website: http://www.beckmancoulter.com . For customers in the United States, if you need replacement product: o Call Client Services at 1-800-854-3633
Quantity in commerce: 2805 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0094-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16

Product code JLW

K221225Class IIAccess TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. / cleared 2022-11-10

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)