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Recall Observatory FDA recall evidence

Device 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.

Z-1471-2017

February 01, 2017

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 76438
Status
Terminated
Classification
Class II
Quantity
US: 94 sales units; OUS: 136 sales units
Official record key
device-enforcement:Z-1471-2017

Official wording

Reason: Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.

Code information: REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01

Distribution pattern: US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.