Z-2482-2010

ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL...

Name: Z-2482-2010 ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL...
Creator: Abbott Laboratories, Inc
Published: 2008-10-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-10-21 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL Product List Number, Part # or Model: 01L86-01 In... on 2008-10-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2482-2010
Status: Terminated
Initiated: 2008-10-21
Posted: 2010-09-23
Terminated: 2012-04-13
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Mixed-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.
Product codes and lots: 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 code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)