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.
FDA Recall Z-1471-2017 · Posted None
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJIH
Date Initiated2017-02-01
Date Terminated2018-06-29
Product QuantityUS: 94 sales units; OUS: 136 sales units
Reason for Recall
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Firm Action
On 2/01/ 2017, URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-036, dated 2/01/2017) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected VITROS Chemistry Products Li Slides to inform them of the issue and to request that they immediately discontinue use of this product. The correction is to the user level. Discuss any concerns regarding previously reported VITROS Li results obtained from the affected with their Laboratory's Medical Director to determine the appropriate course of action. Ortho will be shipping replacement product. ---Foreign affiliates were informed of the issue by e-mail on 2/01/2017 and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. For questions, please contact our Ortho Care(TM) Technical Solutions Center at 1-800-421-3311.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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