Single Analyte DAU Calibrator — Class III medical device recall Z-1270-2014
Terminated recall by Lin-Zhi International Inc, reported 2014-04-02, distributed in CA. Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality c
| Recall number | Z-1270-2014 |
|---|---|
| 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 | 2014-02-18 |
| Classified | 2014-03-21 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-04-25 |
| Distributed | CA |
| Quantity | 120 units |
| Lot numbers | 1308006, 1308131 |
| Model numbers | A53684, A68827 |
| Expiration dates | 2015-03-28 |
Product
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Reason for recall
Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1270-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.