Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Lin-Zhi International Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67521
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1178-2014
  • Date de mise en oeuvre de l'événement
    2014-02-06
  • Date de publication de l'événement
    2014-03-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125666
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Calibrators, drug specific - Product Code DLJ
  • Cause
    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.
  • Action
    Lin-Zhi International, sent an Recall letter dated February 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall letter identified the product by catalog number and product description as well as lot numbers. The reason for recall is explained and that the issue was confirmed by Lin Zhi Quality Control. The 2 affected lots were made with unexpired but dated secondary stock that is the cause of the problem. Lin Zhi requests that customers inform laboratories and customers to properly dispose of any of the affected lots that are still in use or unopened. Lin Zhi should be notified of the amounts for credit. Questions should be directed to 408-732-3883.

Device

Device Recall Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 1 (37.5ng/ml)
  • Modèle / numéro de série
    Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
  • Description du dispositif
    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
    Lin-Zhi International Inc

Manufacturer

Lin-Zhi International Inc
  • Adresse du fabricant
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • Société-mère du fabricant (2017)
    Lin-Zhi International Inc.
  • Source
    USFDA