Recall Z-1471-2017 ยท JIH Flame Photometry, Lithium
Ortho-Clinical Diagnostics
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 multilayer
| Date | Feb 1, 2017 |
| Status | Terminated |
| Reason | Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | US: 94 sales units; OUS: 136 sales units |
| Distribution | US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) Eastman Kodak Company, Jan 26, 1993 |