CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report
Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This recalled
Lin-Zhi International is recalling Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This solution is prepared from, distributed nationwide in the US. The recall was initiated on 6 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1179-2014
- FDA event ID
- 67521
- Recalling firm
- Lin-Zhi International, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2014
- FDA classified
- 12 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 6 Feb 2014 | Recall initiated by company | |
| 12 Mar 2014 | Classified by FDA | +34 days |
| 19 Mar 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
Nationwide AlabamaFloridaGeorgiaLouisianaNorth CarolinaSouth CarolinaTexas
Questions about this recall
Is Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This solution is prepared from recalled?
Yes. Lin-Zhi International recalled Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This solution is prepared from on 6 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1179-2014.
Why was it recalled?
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.
Which lots are affected?
Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.
Where was it sold?
US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lin-Zhi International
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Ethyl Alcohol Enzymatic Assay, (a) recalled by Lin-Zhi International | Lin-Zhi International | Potency & Assay | Nationwide |
| Device | CLASS III | Single Analyte DAU Calibrator Norbuprenorphine: Cutoff Calibrator recalled | Lin-Zhi International | Potency & Assay | CA |
| Device | CLASS II | Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This recalled | Lin-Zhi International | Sterility | Nationwide |
| Device | CLASS III | Single Analyte Urine DAU Control (5 m L Norbuprenorphine recalled | Lin-Zhi International | Potency & Assay | CA |
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