medical Class II Updated 2025-02-05

Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vit

Recalled Product

HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673;
View official government recall

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