Events

Recall of Device Recall Pointe Scientific Hitachi AST Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtest Holdings, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76985
  • Event Risk Class
    Class 3
  • Event Number
    Z-2116-2017
  • Event Initiated Date
    2012-02-15
  • Event Date Posted
    2017-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154862
  • Notes / Alerts
    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.
  • Extra notes in the data
    Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
  • Reason
    A discrepancy was found on hitachi ast (ha7 61) package insert. limitations section indicates linearity is 500 u/l and the performance section linearity is listed as 0-600 u/l, which is not consistent with the 510k submission package insert.
  • Action
    Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313.

Device

Device Recall Pointe Scientific Hitachi AST Reagent
  • Model / Serial
    Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Pointe Scientific Hitachi AST Reagent || R1 : PE plastic bottle w/PP plastic cap. || R2: PE plastic bottle w /PP plastic cap. || Product Usage: || Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
  • Manufacturer
    Medtest Holdings, Inc.

Manufacturer

Medtest Holdings, Inc.
  • Manufacturer Address
    Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
    Medtest Holdings Inc
  • Source
    USFDA