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Lin-Zhi International Recalls
5 recalls on record · December 4, 2013 to May 8, 2019 · Medical Devices
Recalls by year
13
14
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 8, 2019Medical DevicesFDA
Lin-Zhi International Inc recalls Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent
Hazard: Shelf life of the product may be reduced due to degradation of the assay.
April 2, 2014Medical DevicesFDA
Lin-Zhi International Inc recalls Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin
Hazard: 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).
March 19, 2014Medical DevicesFDA
Lin-Zhi International Inc recalls Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should
Hazard: 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.
March 19, 2014Medical DevicesFDA
Lin-Zhi International Inc recalls Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should
Hazard: 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.
December 4, 2013Medical DevicesFDA
Lin-Zhi International Inc recalls Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at
Hazard: 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.