Recall Z-1887-2017 ยท LEH Radioimmunoassay, Vancomycin
Ortho-Clinical Diagnostics
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS
| Date | Feb 21, 2017 |
| Status | Terminated |
| Reason | Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date. |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics sent an IMPORTANT PRODUCT CORRECTION NOTIFICATION letter dated February 21, 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 VANC Reagent lots to inform them of the potential for biased results and to request that they immediately discontinue use of this product. Foreign affiliates were informed by e-mail on February 21, 2017, of the issue and instructed to notify their consignees of the affected product wi |
| Quantity | US: 2740; OUS: 616 |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043386 | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc., Feb 7, 2005 |