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, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
Recall
- Recall Number
- Z-0838-2012
- Event Number
- 60691
- Firm
- Lin-Zhi International Inc
- FEI Number
- 3003610499
- Product Code
- DIF
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- August 5, 2011
- Posted
- January 23, 2012
- Terminated
- January 23, 2012
- Address
- 670 Almanor Ave, Sunnyvale, CA, 94085-3513
Description
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, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
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.
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.
Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
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