Events

Recall of ARCHITECT Total T3 Reagent Kit

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

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
    69289
  • Event Risk Class
    Class 2
  • Event Number
    Z-0474-2015
  • Event Initiated Date
    2014-09-11
  • Event Date Posted
    2014-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130168
  • 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
    Radioimmunoassay, total triiodothyronine - Product Code CDP
  • Reason
    17% of architect total t3 reagent kit, ln 7k64-20/-25 reagent lots 38901ui00 and 38901ui01 may exhibit lower relative light units (rlus) than expected, which in turn may result in controls out of range or patient results higher than expected.
  • Action
    Abbott sent an Product Recall letter dated September 11, 2014, to all direct accounts (customers). The letters included instructions for customers to: 1) Discontinue use of and destroy any remaining inventory according to your laboratory procedures; 2) follow your laboratory protocol regarding the need for review of previously reported patient results; 3) replacement material is available; for ordering, please order through your normal ordering process; and, 4) if you have forwarded any of the affected lots to another laboratory, please provide them with a copy of this communication. Customers or healthcare providers with questions can contact Customer Service at 1-877-422-2688 (24 hours a day, 7 days a week).

Device

ARCHITECT Total T3 Reagent Kit
  • Model / Serial
    Product List Numbers, Lot Numbers, and Expiration Dates:   1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15;  2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.
  • Product Description
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: || - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. || - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. || The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
  • Manufacturer
    Abbott Ireland Diagnostics Division

Manufacturer

Abbott Ireland Diagnostics Division
  • Manufacturer Address
    Abbott Ireland Diagnostics Division, Lisnamuck, Co. Longford Ireland
  • 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