The Recall Desk

Manufacturer

Lin-Zhi International Inc

5 recalls in our database name Lin-Zhi International Inc as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2019-05-08

Of the 5 recalls from Lin-Zhi International Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • LowFDA (Devices)·Z-1256-2019·2019-05-08

    Lin-Zhi International Recalls Ethyl Alcohol Enzymatic Assay Kits

    Lin-Zhi International Inc is recalling 49 Ethyl Alcohol Enzymatic Assay kits due to potential detergent contamination that may reduce shelf life.

    Product
    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1270-2014·2014-04-02

    Lin-Zhi Norbuprenorphine Calibrator Recalled for Quality Control Failure

    Lin-Zhi International is recalling Norbuprenorphine cutoff calibrators because they failed quality control testing. The product is used for in vitro diagnostic calibration.

    Product
    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1178-2014·2014-03-19

    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
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1179-2014·2014-03-19

    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
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0386-2014·2013-12-04

    Lin-Zhi International Recalls Norbuprenorphine Urine Control Material

    Lin-Zhi International is recalling Norbuprenorphine Level 2 Controls because the analyte degrades, causing decreased concentration readings.

    Product
    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, I
    Category
    Medical Device
    Distribution
    1 state