Device Recall Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 1 (37.5ng/ml)

  • Model / Serial
    Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
  • Product Description
    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 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • Manufacturer Parent Company (2017)
  • Source
    USFDA