Events

Recall of Device Recall Sterling Diagnostics, Inc., Urea Nitrogen/Color BUN (Enzymatic Berthelot)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sterling Diagnostics, 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
    75591
  • Event Risk Class
    Class 3
  • Event Number
    Z-0936-2017
  • Event Initiated Date
    2016-07-20
  • Event Date Posted
    2016-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150902
  • 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
    Berthelot indophenol, urea nitrogen - Product Code CDL
  • Reason
    Sterling diagnostics, inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
  • Action
    Sterling Diagnostics, Inc. initiated their voluntary recall on 07/20/2016 by calling customers by phone to determine what kits remianed at customers' and compare withthe firm's sales records. Sterling Diagnostics followed up by sending a letter to each customer, and instructed them to take note of the corrected expiration dates for the dignostic kits, apply the revised dates to the kits in their possession, and return a customer acknowledgement to the Office Manager Luz Santa Maria at Sterling Diagnostics, Inc. at 36645 Metro Court, Sterling Heights, MI 48312. Customers with questions can call 586-979-2141.

Device

Device Recall Sterling Diagnostics, Inc., Urea Nitrogen/Color BUN (Enzymatic Berthelot)
  • Model / Serial
    Urea Nitrogen/Color BUN, CAT No. 2290-L  , Lot No. 29051, Expriry: 9/18, Manufactured: 09/21/15
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: MI Foreign: Phillipines VA/DOD: None
  • Product Description
    Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
  • Manufacturer
    Sterling Diagnostics, Inc.

Manufacturer

Sterling Diagnostics, Inc.
  • Manufacturer Address
    Sterling Diagnostics, Inc., 36645 Metro Ct, Sterling Heights MI 48312-1009
  • Manufacturer Parent Company (2017)
    Sterling Diagnostics Inc
  • Source
    USFDA