Recall Z-1471-2017— Ortho-Clinical Diagnostics

Name: FDA recall Z-1471-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-01

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2017-02-01, terminated 2018-06-29. It names one FDA 510(k) clearance: K924488. 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.. Reason: Intermittent imprecision in results generated using two specific lots of VITROS Li Slides..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2017-02-01
Terminated: 2018-06-29
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K924488 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)Eastman Kodak Company·cleared 1993-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.