The Recall Desk

FDA (Devices) recall action 67521

Lin-Zhi International Inc recalled 2 products on 2014-03-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-03-19
Critical
0
Units
346

Why these products were 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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2014-03-19

    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.

    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
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2014-03-19

    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.

    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 liqu
    Category
    Distribution
    7 states