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Recall Observatory FDA recall evidence

Device product

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

Z-1887-2024

April 23, 2024

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 94495
Status
Ongoing
Classification
Class II
Quantity
488 units (33 US, 455 OUS)
Official record key
device-enforcement:Z-1887-2024

Official wording

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

Code information: Catalog # L2KTG6, SMN 10381655, UDI/DI: 00630414962115, Lot #s: 785, 790, 791, 793.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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