Recall Z-0868-2012 ยท DKB Calibrators, Drug Mixture
Lin-Zhi International Inc
Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.
| Date | Jan 25, 2012 (initiated Aug 23, 2011) |
| Status | Terminated |
| Reason | Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D regardin |
| Quantity | 45 items |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc., Jun 24, 2005 |