Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls
Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.
What this means for you
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 in a quality control product rather than direct physical injury or acute illness, fitting the Moderate criteria for minor labeling or performance errors.
Plain-English summary
Lin-Zhi International Inc. is recalling 130 items of Cannabinoid DAU Calibrator Control Level 1 (37.5 ng/mL) and Level 2 (62.5 ng/mL). The affected products are identified by catalog numbers 0007c and 0008c, lot number 1211158R, and an expiration date of May 14, 2014. These products are 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 is due to the use of dated but unexpired secondary stock in the creation of the products. This issue may cause the controls to give decreased concentration readings towards the end of their shelf life. The products are human urine-based liquids and should be handled as potentially infectious.
The affected units were distributed in the United States to the states of 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 the manufacturer for further instructions.
The recalled product
- Product
- Cannabinoids DAU Calibrator Control Level 1 (37.5 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 liqu
- Manufacturer
- Lin-Zhi International Inc
- Affected units
- 130
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 0007Cm
- lot number 1211158R
- 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.
See all 2 products in this recall →Related recalls
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