Events

Recall of iStat cTnI cartridges

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point Of Care 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
    60048
  • Event Risk Class
    Class 2
  • Event Number
    Z-0180-2012
  • Event Date Posted
    2011-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104309
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Reason
    I-stat ctni cartridges beginning with letter "t" may exhibit a higher than expected variability in reported results. this increased variability may result in falsely elevated or falsely depressed results.
  • Action
    APOC issued Urgent Recall Notices/Business Reply Forms dated September 2011 to consignees. The letter identified the affected product and explained the background of the problem. Customers are to discontinue use of the cartridges from the lots identified. All unused product will be credited and should be returned as instructed on the attached Business Reply Card. If the affected product was further distributed, a copy of the Recall Notice should be provided to those customers as well. APOC shipped replacement product in order to minimize any disruption. If replacement product has not been received then customers should contact Customer Service at 1-800-366-8020, option 5. Questions regarding this information should be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1 or customers' local APOC representative.

Device

iStat cTnI cartridges
  • Model / Serial
    List Number 03P90-25; 06F15-03; 06F15-04; 600-9009-25  All lots beginning with letter T.  Various lots.  LOT List Number EXP. DATE T11059 03P90-25 28-Sep-11 T11059A 03P90-25 28-Sep-11 T11059B 03P90-25 28-Sep-11 T11060 03P90-25 28-Sep-11 T11060A 03P90-25 28-Sep-11 T11060B 03P90-25 28-Sep-11 T11061 03P90-25 28-Sep-11 T11061A 03P90-25 28-Sep-11 T11061C 03P90-25 28-Sep-11 T11062A 03P90-25 28-Sep-11 T11062B 03P90-25 28-Sep-11 T11063 03P90-25 28-Sep-11 T11063A 03P90-25 28-Sep-11 T11064 03P90-25 28-Sep-11 T11065 03P90-25 28-Sep-11 T11066 03P90-25 28-Sep-11 T11067 03P90-25 28-Sep-11 T11068 06F15-03 28-Sep-11 T11068A 03P90-25 28-Sep-11 T11068B 03P90-25 28-Sep-11 T11069 06F15-03 28-Sep-11 T11069A 03P90-25 28-Sep-11 T11069B 03P90-25 28-Sep-11 T11070 03P90-25 28-Sep-11 T11070A 03P90-25 28-Sep-11 T11070B 03P90-25 28-Sep-11 T11070C 03P90-25 28-Sep-11 T11070D 03P90-25 28-Sep-11 T11072 03P90-25 28-Sep-11 T11072A 03P90-25 28-Sep-11 T11073 06F15-03 28-Sep-11 T11073A 03P90-25 28-Sep-11 T11073B 03P90-25 28-Sep-11 T11074 03P90-25 14-Oct-11 T11074A 03P90-25 14-Oct-11 T11075 03P90-25 14-Oct-11 T11075A 03P90-25 14-Oct-11 T11075B 03P90-25 14-Oct-11 T11076 06F15-03 14-Oct-11 T11076A 03P90-25 14-Oct-11 T11076B 03P90-25 14-Oct-11 T11077 03P90-25 14-Oct-11 T11077A 03P90-25 14-Oct-11 T11078 03P90-25 14-Oct-11 T11079 03P90-25 14-Oct-11 T11079A 03P90-25 14-Oct-11 T11080 06F15-03 14-Oct-11 T11081 03P90-25 14-Oct-11 T11081A 03P90-25 14-Oct-11 T11081B 06F15-03 14-Oct-11 T11082 03P90-25 14-Oct-11 T11083 03P90-25 14-Oct-11 T11083A 03P90-25 14-Oct-11 T11083B 03P90-25 14-Oct-11 T11084 03P90-25 14-Oct-11 T11084A 03P90-25 14-Oct-11 T11087 03P90-25 14-Oct-11 T11088 03P90-25 28-Oct-11 T11088A 03P90-25 28-Oct-11 T11089A 03P90-25 28-Oct-11 T11089B 03P90-25 28-Oct-11 T11090 03P90-25 28-Oct-11 T11091 03P90-25 28-Oct-11 T11091A 03P90-25 28-Oct-11 T11091B 03P90-25 28-Oct-11 T11092 03P90-25 28-Oct-11 T11095 03P90-25 28-Oct-11 T11095A 03P90-25 28-Oct-11 T11096 03P90-25 28-Oct-11 T11096C 03P90-25 28-Oct-11 T11096D 03P90-25 28-Oct-11 T11097 03P90-25 28-Oct-11 T11097B 03P90-25 28-Oct-11 T11098 03P90-25 28-Oct-11 T11099 03P90-25 28-Oct-11 T11099A 03P90-25 28-Oct-11 T11100 03P90-25 28-Oct-11 T11101 03P90-25 28-Oct-11 T11101A 03P90-25 28-Oct-11 T11102 03P90-25 28-Oct-11 T11102A 03P90-25 28-Oct-11 T11102B 03P90-25 28-Oct-11 T11103 03P90-25 28-Oct-11 T11103A 03P90-25 28-Oct-11 T11104A 03P90-25 28-Oct-11 T11104B 06F15-03 28-Oct-11 T11105 06F15-03 14-Nov-11 T11105A 06F15-03 14-Nov-11 T11105B 06F15-03 14-Nov-11 T11107 03P90-25 14-Nov-11 T11107A 03P90-25 14-Nov-11 T11108 03P90-25 14-Nov-11 T11108A 03P90-25 14-Nov-11 T11108B 03P90-25 14-Nov-11 T11109 06F15-03 14-Nov-11 T11109B 06F15-03 14-Nov-11 T11110 03P90-25 14-Nov-11 T11110A 03P90-25 14-Nov-11 T11110B 03P90-25 14-Nov-11 T11110C 03P90-25 14-Nov-11 T11111 03P90-25 14-Nov-11 T11111A 03P90-25 14-Nov-11 T11112A 03p90-25 14-Nov-11 T11112B 03P90-25 14-Nov-11 T11113 03P90-25 14-Nov-11 T11113A 03P90-25 14-Nov-11 T11114 03P90-25 14-Nov-11 T11114A 03p90-25 14-Nov-11 T11115 03P90-25 14-Nov-11 T11115A 03P90-25 14-Nov-11 T11116 03P90-25 14-Nov-11 T11116A 06F15-03 14-Nov-11 T11117 03P90-25 14-Nov-11 T11118 03P90-25 14-Nov-11 T11118A 03P90-25 14-Nov-11 T11118B 03P90-25 14-Nov-11 T11118C 03P90-25 14-Nov-11 T11119 03P90-25 28-Nov-11 T11120 03P90-25 28-Nov-11 T11120A 03P90-25 28-Nov-11 T11121 03P90-25 28-Nov-11 T11121A 06F15-03 28-Nov-11 T11122 06f15-03 28-Nov-11 T11123 03P90-25 28-Nov-11 T11123B 03P90-25 28-Nov-11 T11123C 03P90-25 28-Nov-11 T11124 03P90-25 28-Nov-11 T11124A 03P90-25 28-Nov-11 T11124B 03P90-25 28-Nov-11 T11125 03P90-25 28-Nov-11 T11125A 03P90-25 28-Nov-11 T11125C 03P90-25 28-Nov-11 T11126 03P90-25 28-Nov-11 T11127 03P90-25 28-Nov-11 T11127A 03P90-25 28-Nov-11 T11128 03P90-25 28-Nov-11 T11128B 03P90-25 28-Nov-11 T11129A 03P90-25 28-Nov-11 T11129B 03P90-25 28-Nov-11 T11131A 03P90-25 28-Nov-11 T11132 03P90-25 28-Nov-11 T11132A 03P90-25 28-Nov-11 T11132B 03P90-25 28-Nov-11 T11133 03P90-25 28-Nov-11 T11136 03P90-25 14-Dec-11 T11136A 03P90-25 14-Dec-11 T11137 03P90-25 14-Dec-11 T11137A 03P90-25 14-Dec-11 T11137B 03P90-25 14-Dec-11 T11138 06F15-03 14-Dec-11 T11138A 06F15-03 14-Dec-11 T11138B 06F15-03 14-Dec-11 T11139 03P90-25 14-Dec-11 T11139A 03P90-25 14-Dec-11 T11139B 03P90-25 14-Dec-11 T11140 03P90-25 14-Dec-11 T11142 03P90-25 14-Dec-11 T11143 03P90-25 14-Dec-11 T11143A 03P90-25 14-Dec-11 T11144 03P90-25 14-Dec-11 T11144A 03P90-25 14-Dec-11 T11145A 03P90-25 14-Dec-11 T11147 03P90-25 14-Dec-11 T11147A 03P90-25 14-Dec-11 T11149 03P90-25 28-Dec-11 T11150 03P90-25 28-Dec-11 T11150A 03P90-25 28-Dec-11 T11151 03P90-25 28-Dec-11 T11151A 03P90-25 28-Dec-11 T11151B 03P90-25 28-Dec-11 T11153 03P90-25 28-Dec-11 T11153A 03P90-25 28-Dec-11 T11153B 03P90-25 28-Dec-11 T11154 06F15-03 28-Dec-11 T11156 06F15-03 28-Dec-11 T11156A 03P90-25 28-Dec-11 T11157 03P90-25 28-Dec-11 T11158 03P90-25 28-Dec-11 T11158B 03P90-25 28-Dec-11 T11159 03P90-25 28-Dec-11 T11160 03P90-25 28-Dec-11 T11163A 03P90-25 28-Dec-11 T11164 03P90-25 28-Dec-11 T11165C 03P90-25 28-Dec-11 T11166 03P90-25 14-Jan-11 T11167 06F15-03 14-Jan-11 T11172 03P90-25 14-Jan-11 T11172A 03P90-25 14-Jan-11 T11173 03P90-25 14-Jan-11 T11174 03P90-25 14-Jan-11 T11174B 03P90-25 14-Jan-11 T11175 06F15-03 14-Jan-11 T11177 03P90-25 14-Jan-11 T11186 03P90-25 28-Jan-11 T11202 06F15-03 28-Jan-11
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    i-Stat cTnI cartridges || Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.
  • Manufacturer
    Abbott Point Of Care Inc.

Manufacturer

Abbott Point Of Care Inc.
  • Manufacturer Address
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA