—#209933

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.

FDA product code: JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K221225
Affected lot / code info: UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251

Why it was recalled

Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-08-28
Posted by FDA: 2024-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.