Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.

Hazard

The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.

Details from the source

Reason for recall: The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab. Distribution: Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Finland, France, Germany, Greece Guatemala, Honduras, Hong Kong, H Quantity: 488 units (33 US, 455 OUS) Lot/code info: Catalog # L2KTG6, SMN 10381655, UDI/DI: 00630414962115, Lot #s: 785, 790, 791, 793.

UPC codes

00630414962115

Source

Official record: FDA (Device enforcement) ↗

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