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.
FDA Recall Z-0838-2012 · Posted 2012-01-23
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Recalling FirmLin-Zhi International Inc
Recall StatusTerminated
Product CodeDIF
Date Initiated2011-08-05
Date Terminated2012-01-23
Product Quantity107 items kitted
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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