—#153213

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.

FDA product code: JIH — Flame Photometry, Lithium
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K924488
Affected lot / code info: REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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

Timeline

Recall initiated: 2017-02-01
Terminated: 2018-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.