RegWardenFDA facility compliance records
Facility

LIN-ZHI INTERNATIONAL, INC.

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 2 recalls; 2019: 1 recalls1’132’14’15’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (4)

Devices registered here (3)

  • Enzyme Immunoassay, Cannabinoids
    Product code LDJ (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3870
  • Calibrators, Drug Specific
    Product code DLJ (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3200
  • Drug Specific Control Materials
    Product code LAS (opens in a new tab) · Class I · Clinical Toxicology · 21 CFR 862.3280

Recalls & enforcement

  • Class IIITerminated2019-01-11
    Shelf life of the product may be reduced due to degradation of the assay.
  • Class IIITerminated2014-02-18
    Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
  • Class IITerminated2014-02-06
    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 …
  • Class IIITerminated2013-10-03
    Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LIN-ZHI INTERNATIONAL, INC. (FEI 3003610499) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003610499-lin-zhi-international-inc/

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