Recall Z-0629-2011 ยท DLJ Calibrators, Drug Specific
Abbott Laboratories
ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25 The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA
| Date | Dec 16, 2010 (initiated Sep 13, 2010) |
| Status | Terminated |
| Reason | The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment. |
| Root cause | Other |
| Action | Abbott Laboratories issued a Product Correction letters dated September 13 and 15, 2010 to all customers that received ARCHITECT iVancomycin reagents in the last 12 months. In the September 13, 2010 letter, the accounts were informed of the falsely elevated results and were instructed to continue to follow all sample handling instruction in the package insert and to take the following additional actions to mitigate the risk of obtaining an incorrect result: 1. After following the primary tube manufacturer's recommended centrifugation instructions transfer serum or plasma for all specimens to a |
| Quantity | 2,411 kits |
| Distribution | Worldwide Distribution: Throughout USA, including Puerto Rico, and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Mala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 Biokit, S.A., Mar 19, 2008 |