Recall Z-0847-2012 ยท DKB Calibrators, Drug Mixture
Lin-Zhi International Inc
Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi Internati
| Date | Jan 25, 2012 (initiated Oct 11, 2011) |
| Status | Terminated |
| Reason | Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators. |
| Root cause | Labeling mix-ups |
| Action | Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions |
| Quantity | 49 items |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the 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 |