Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls Due to Concentration Drift
Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential inaccurate readings (quality control failure) rather than direct physical injury or infection, fitting the Moderate criteria for low-risk contamination or labeling/quality issues without reported harm.
Plain-English summary
Lin-Zhi International Inc. is recalling 216 items of Cannabinoid DAU Calibrator Control Level 1 (Catalog #0008c) and Level 2 (Catalog #0007c). The affected products include Lot 1211160R with an expiration date of May 14, 2014. These products are human urine-based liquids used as assay quality control material to monitor the precision of the Lin-Zhi International Cannabinoid Enzyme Immunoassay on automated clinical chemistry analyzers.
The recall was initiated because the products may give decreased concentration readings towards the end of their shelf life. This issue is attributed to the use of dated but unexpired secondary stock in the creation of the products. The affected units were distributed in the United States, including South Carolina, North Carolina, Louisiana, Florida, Texas, Alabama, and Georgia, as well as internationally to Germany.
Users of these products should stop using the affected lots and contact Lin-Zhi International Inc. for further instructions. The products are prepared from non-sterile urine and should be handled as potentially infectious.
The recalled product
- 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…
- Manufacturer
- Lin-Zhi International Inc
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog number 0008c
- lot number 1211160R
- Expiration May 14
- 2014.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lin-Zhi International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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