Z-0868-2012

Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use...

Name: Z-0868-2012 Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use...
Creator: Lin-Zhi International Inc
Published: 2011-08-23
License: https://open.fda.gov/license/

Lin-Zhi International Inc / initiated 2011-08-23 / Terminated / root cause: manufacturing process

FDA source

Lin-Zhi International Inc began a recall of Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave... on 2011-08-23. The reason FDA records is "Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0868-2012
Status: Terminated
Initiated: 2011-08-23
Posted: 2012-01-25
Terminated: 2012-01-25
Recalling firm: Lin-Zhi International Inc
Product: Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.
Product code: DKB Calibrators, Drug Mixture
Reason for recall: Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: [email protected] or webpage: www.lin-zhi.com.
Quantity in commerce: 45 items
Distribution: Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
Product codes and lots: Catalog number 0803; Lot 1101136K3, exp 1/28/13

Product code DKB

K051088Class IIMultiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. / cleared 2005-06-24

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)