Events

Recall of Device Recall SeNova Blood Glucose Test Strips

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

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
    32883
  • Event Risk Class
    Class 2
  • Event Number
    Z-1546-05
  • Event Initiated Date
    2005-03-14
  • Event Date Posted
    2005-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41027
  • 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
    Glucose Dehydrogenase, Glucose - Product Code LFR
  • Reason
    A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
  • Action
    Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.

Device

Device Recall SeNova Blood Glucose Test Strips
  • Model / Serial
    Lot numbers: 407061, 4071601, 4071901, 4071902, 4072001, 4072002, 4072201, 4072202, 4072801, 4072802, 4072901, 4072902, 4073001; 4080301, 4080302, 4080303, 4080401, 4080402, 4080601, 4081101, 4081102, 4081601, 4081901, 4082001, 4082002, 4082301, 4082501, 4082502, 4082701, 4083101, 4083102, 4090101, 4090201, 4091601, 4091702, 4092101, 4092201, 4092301, 4092401, 4092701, 4092801, 4092901, 4100101, 4100401, 4100402, 4100501, 4100601, 4101101, 4101201, 4101301, 4101401, 4101801, 4102201, 4102502, 4102601, 4102701, 4102801, 4102901, 4110401, 4110501, 4111101, 4111601 and 4111602.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.
  • Product Description
    SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
  • Manufacturer
    CHdiagnostics

Manufacturer

CHdiagnostics
  • Manufacturer Address
    CHdiagnostics, 1 Carlson Pkwy N, Plymouth MN 55447-4440
  • Source
    USFDA