QUIDELORTHO: VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (E

Hazard

Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.

Details from the source

Reason for recall: Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore , Spain, Sweden, The Netherlands, United Kingdom. Quantity: N/A Lot/code info: UDI-DI: 10758750008438 Lot Numbers: 3042 Expiry: 09-Apr-2024; 3052 Expiry: 02-May-2024; 3061 Expiry: 06-Jun-2024; 3080 Expiry: 02-May-2024; 3090 Expiry: 14-Jun-2024; 3100 Expiry: 29-Jul-2024; 3110 Expiry: 13-Aug-2024; 3126 Expiry: 04-Sep-2024

UPC codes

10758750008438

Source

Official record: FDA (Device enforcement) ↗

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