Z-1270-2014Class III

Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use...

Name: Z-1270-2014 Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use...
Creator: Lin-Zhi International Inc
Published: 2014-02-18
License: https://open.fda.gov/license/

Lin-Zhi International Inc / initiated 2014-02-18 / Terminated / root cause: packaging

FDA source

Lin-Zhi International Inc began a recall of Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The... on 2014-02-18. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1270-2014
Classification: Class III
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-03-21
Terminated: 2014-04-25
Recalling firm: Lin-Zhi International Inc
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
Product code: DJG Enzyme Immunoassay, Opiates
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).
Root cause tag: packaging
FDA root cause: Packaging
Action: Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.
Quantity in commerce: 120 units, 60 of each lot number
Distribution: US Distribution including CA.
Product codes and lots: Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1270-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1270-2014	Class III	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21

Product code DJG

K081008Class IIBuprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron SystemsLin-Zhi International, Inc. / cleared 2008-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)