Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Alma
FDA device recall Z-0838-2012 · posted 2012-01-23 · Terminated
Recall details
- Recalling firm
- Lin-Zhi International Inc
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DIF
- Quantity affected
- 107 items kitted
- Distribution
- Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
- Date initiated
- 2011-08-05
- Date posted
- 2012-01-23
- Date terminated
- 2012-01-23
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088) | Lin-Zhi International, Inc. | 2005-06-24 |