Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
Reason for recall: Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range. Distribution: Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Korea (the Republic of), Kuwait, Kyrgyzstan, Lebanon, Lithua Quantity: 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026) Lot/code info: Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673; ****Lot numbers added 4/15/2026**** N0531891, N0733658, N0249207, N0442161, N0744673, N1147734, N020463, N0250464, N0452277, N0553155, N0754506;
08426950472483
Official record: FDA (Device enforcement) ↗
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