Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.
Showing 281–300 of 400 recalls
Philips Healthcare Informatics, Inc.
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Bio-Rad Labs
An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.