Z-1179-2014Class II

Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and...

Name: Z-1179-2014 Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and...
Creator: Lin-Zhi International Inc
Published: 2014-02-06
License: https://open.fda.gov/license/

Lin-Zhi International Inc / initiated 2014-02-06 / Terminated / root cause: manufacturing process

FDA source

Lin-Zhi International Inc began a recall of Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD... on 2014-02-06. FDA classified it as Class II and gives the reason as "Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use...". 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-1179-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-06
Posted: 2014-03-12
Terminated: 2015-03-10
Recalling firm: Lin-Zhi International Inc
Product: Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Lin-Zhi International, sent an Recall letter dated February 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall letter identified the product by catalog number and product description as well as lot numbers. The reason for recall is explained and that the issue was confirmed by Lin Zhi Quality Control. The 2 affected lots were made with unexpired but dated secondary stock that is the cause of the problem. Lin Zhi requests that customers inform laboratories and customers to properly dispose of any of the affected lots that are still in use or unopened. Lin Zhi should be notified of the amounts for credit. Questions should be directed to 408-732-3883.
Quantity in commerce: 216 items
Distribution: US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
Product codes and lots: Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1179-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1178-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1179-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12

Product code JJW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)