FDA Device recall Z-1270-2014
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator
- FDA Device
- Class III
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class III recall of Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator by Lin Zhi International, citing 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 concentrati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1270-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-02-18 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lin Zhi International |
| Distribution | CA |
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
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).
Identifiers
| code_info | Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1270-2014%22
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