Abbott Laboratories, Inc 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. Recall
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According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
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
Products Sold
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.
Abbott Laboratories, Inc is recalling ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott due to During manufacturing, two components of the ARCHITECT i1000SR were reversed which could potentially cause falsely elevated patient results due to a s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, FL, GA, IL, LA, MA, MN, NY, OH, OK, TX, UT, WV, DC
Page updated: Jan 10, 2026