Recall Z-2145-2016 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and c
| Date | May 9, 2016 |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter (Ref. CL2016-098) dated 5/9/2016, 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 product. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue distributing and discard the affected lots; complete and return the Confirmation of Receipt form by May 18, 2016 via Fax to 1.888.557.3759 or 1.585.453.4110 or scan to PDF |
| Quantity | US: Lot 6471 - 282, Lot 6480 - 344 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY Ortho-Clinical Diagnostics, Inc., Dec 18, 1998 |