Z-0386-2014Class III

Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only...

Name: Z-0386-2014 Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only...
Creator: Lin-Zhi International Inc
Published: 2013-10-03
License: https://open.fda.gov/license/

Lin-Zhi International Inc / initiated 2013-10-03 / Terminated

FDA source

Lin-Zhi International Inc began a recall of 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... on 2013-10-03. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0386-2014
Classification: Class III
Status: Terminated
Initiated: 2013-10-03
Posted: 2013-11-25
Terminated: 2013-12-26
Recalling firm: Lin-Zhi International Inc
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.
Product code: LAS Drug Specific Control Materials
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.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center Via our website, http://www.beckmancoulter.com/customersupport/support Via phone, call 1-800-854-3633 in the United States Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.
Quantity in commerce: 60 items
Distribution: US Distribution in CA.
Product codes and lots: Catalog #A68825, Lot #1307086; Exp. 3/28/2014/

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0386-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0386-2014	Class III	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-25

Product code LAS

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)