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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i1000SR" Processing Module

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 Class 2 Recall
ARCHITECT i1000SR" Processing Module
see related information
Date Posted September 23, 2010
Recall Status1 Terminated on April 13, 2012
Recall Number Z-2482-2010
Recall Event ID 55360
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving, Texas 75038-4313
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .
Quantity in Commerce 404 units distributed worldwide (including US)
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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