Events

Recall of ARCHITECT i1000SR" Processing Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories, 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
    55360
  • Event Risk Class
    Class 2
  • Event Number
    Z-2482-2010
  • Event Initiated Date
    2008-10-21
  • Event Date Posted
    2010-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90666
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    During manufacturing, two components of the architect i1000sr were reversed which could potentially cause falsely elevated patient results due to a sample-reagent and reagent-sample carryover.
  • Action
    ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .

Device

ARCHITECT i1000SR" Processing Module
  • Model / Serial
    Serial Numbers: (1st recall) i1SR01001-1224; 1226-1300; 1302-1306; 1308-1313; 1315-1316; 1318-1352; 1355-1363; 1365; 1376; 1381-1382  Extended to include serial numbers manufactured from 04/01/08 to 03/31/09: i1SR01021, 1026, 1032, 1040, 1036, 1043, 1059, 1065, 1069, 1071, 1071, 1074, 1082, 1094, 1106, 1107, 1109, 1111, 1112, 1114, 1117, 1119, 1121, 1123, 1128, 1133, 1135, 1138, 1139, 1158, 1162, 1167, 1171, 1173, 1177, 1183, 1186, 1188, 1189, 1198, 1200, 1201, 1205, 1209, 1211, 1217, 1225, 1230, 1243, 1246, 1249, 1250, 1260, 1262, 1272, 1277, 1279, 1284, 1286-1288, 1290, 1294, 1301, 1304, 1312, 1317, 1321, 1324-1327, 1332-1335, 1338, 1339, 1342-1345, 1347, 1348, 1351-1356, 1363-1368, 1370-1372, 1375, 1377-1387, 1389-1396, 1398-1410, 1412-1414, 1416-1441, 1443-1530, 1532-1536 (some of these #'s were removed whose field status was Demo/Training and instruments that had TSB 117-004 completed prior to Feb 19.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution:USA including states of: CO, DC, FL, GA, IL, LA, MA, MN, NY, OH, OK, TX, UT, and WV and countries including: Australia, Brazil, Bogota, Canada, China WFOTC, Columbia, Curacao (NETH ANT), Germany, Hong Kong, Japan, Mexico, Singapore, and Taiwan.
  • Product Description
    ARCHITECT¿ i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL || Product List Number, Part # or Model: 01L86-01 || In Vitro Diagnostic use only. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests, utilizing photometry and potentiometric technology, and Immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • 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