Recall Z-0838-2012
Lin-Zhi International Inc · initiated August 5, 2011
Product
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.
Codes / lots: Catalog # 0808, lot number 1101137, Exp 1/28/2013
Reason for recall
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0838-2012
- Initiated
- August 5, 2011
- Posted by FDA
- January 23, 2012
- Terminated
- January 23, 2012
- Product code
- DIF – Drug Mixture Control Materials
- Quantity
- 107 items kitted
- Distribution
- Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
- Recalling firm
- Lin-Zhi International Inc, Sunnyvale, CA