Recall Z-0838-2012 ยท DIF Drug Mixture Control Materials
Lin-Zhi International Inc
Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbit
| Date | Jan 23, 2012 (initiated Aug 5, 2011) |
| Status | Terminated |
| Reason | Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators. |
| Root cause | Error in labeling |
| Action | Lin Zhi International, Inc. sent a Recall notification letter dated August 5, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to determine whether they wanted credit or a replacement product. The incorrectly labeled product should be disposed of properly. For questions regarding this recall call 408-732-3856. |
| Quantity | 107 items kitted |
| Distribution | Nationwide Distribution including MA, FL, NC, NH, WA, and IN. |
| 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 |