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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per s
Recalled March 22, 2017 · FDA recall Z-1471-2017 · Ortho-Clinical Diagnostics
Hazard
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. · FDA Class II
Units
US: 94 sales units; OUS: 136 sales units
Sold at
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
Description
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Product
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →