Beckman Coulter, Inc.: The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH,

Hazard

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

Details from the source

Reason for recall: Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. 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. Quantity: 2805 units Lot/code info: UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251

UPC codes

15099590744373

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.