Single Analyte Urine DAU Control — Class III medical device recall Z-0386-2014
Terminated recall by Lin-Zhi International Inc, reported 2013-12-04, distributed in CA. Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading du
| Recall number | Z-0386-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lin-Zhi International Inc, Sunnyvale, CA, United States |
| Recall initiated | 2013-10-03 |
| Classified | 2013-11-25 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2013-12-26 |
| Distributed | CA |
| Quantity | 60 items |
| Reason classes | specification failure |
| Lot numbers | 1307086 |
| Model numbers | A68825 |
| Expiration dates | 2014-03-28 |
Product
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
Reason for recall
Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.