Medical Device Recall: IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Siemens Healthcare Diagnostics, Inc. · April 23, 2024
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, Hungary, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Vietnam.
States Affected
NATIONWIDE
Quantity Affected
488 units (33 US, 455 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1887-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.