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Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 U
Recalled October 5, 2022 · FDA recall Z-1820-2022 · Siemens Healthcare Diagnostics
Hazard
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid · FDA Class II
Units
100 units US; 328 units OUS
Sold at
Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH TX UT and OUS (Foreign) countries of: Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ P.R.¿China¿¿¿¿¿ Singapore¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿
Description
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
Product
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →