Events

Recall of Device Recall HemoCue Hb 201 Microcuvettes

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

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
    65920
  • Event Risk Class
    Class 2
  • Event Number
    Z-0101-2014
  • Event Initiated Date
    2013-07-25
  • Event Date Posted
    2013-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120868
  • 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
    Automated hemoglobin system - Product Code GKR
  • Reason
    Hemocue ab has become aware of a production related problem involving punctured hemocue hb 201 microcuvettes single pack pouches.
  • Action
    On 8/13/2013 the firm sent Field Safety Notices to their customers.

Device

Device Recall HemoCue Hb 201 Microcuvettes
  • Model / Serial
    Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737.   Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738.   Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727.  Part Number 116101; Lot Numbers: 1303730 & 1303735.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.
  • Product Description
    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
  • Manufacturer
    HemoCue AB

Manufacturer

HemoCue AB
  • Manufacturer Address
    HemoCue AB, Kuvettgaten 1, Angelholm Sweden
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA