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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
cGMP Deviations: deviations leading to potential cross-contamination.
Potential for intraoperative screw head separation at weld location.