Home / Recalls / Abbott Laboratories, Inc / Z-0749-2022

Z-0749-2022 Class II Ongoing

Recalled by Abbott Laboratories, Inc — Irving, TX

FDA device recall Z-0749-2022 was initiated by Abbott Laboratories, Inc on Feb 3, 2022 and is designated Class II. Reason for recall: Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe. The recall status is ongoing. Affected quantity: 306 units.

Recall Details

Product Type
Devices
Report Date
Mar 23, 2022
Initiation Date
Feb 3, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
306 units

Product Description

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

Reason for Recall

Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

Distribution Pattern

Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan Kuwait and Mexico.

Code Information

Serial numbers AS1001 through AS1387 UDIs: (01)00380740138479(21)AS1002 (01)00380740138479(21)AS1005 (01)00380740138479(21)AS1009 (01)00380740138479(21)AS1012 (01)00380740138479(21)AS1013 (01)00380740138479(21)AS1016 (01)00380740138479(21)AS1019 (01)00380740138479(21)AS1023 (01)00380740138479(21)AS1028 (01)00380740138479(21)AS1031 (01)00380740138479(21)AS1032 (01)00380740138479(21)AS1044 (01)00380740138479(21)AS1058 (01)00380740138479(21)AS1064 (01)00380740138479(21)AS1097 (01)00380740138479(21)AS1126 (01)00380740138479(21)AS1148 (01)00380740138479(21)AS1153 (01)00380740138479(21)AS1155 (01)00380740138479(21)AS1160 (01)00380740138479(21)AS1161 (01)00380740138479(21)AS1193 (01)00380740138479(21)AS1212 (01)00380740138479(21)AS1213 (01)00380740138479(21)AS1215 (01)00380740138479(21)AS1217 (01)00380740138479(21)AS1218 (01)00380740138479(21)AS1219 (01)00380740138479(21)AS1220 (01)00380740138479(21)AS1221 (01)00380740138479(21)AS1222 (01)00380740138479(21)AS1224 (01)00380740138479(21)AS1225 (01)00380740138479(21)AS1226 (01)00380740138479(21)AS1227 (01)00380740138479(21)AS1230 (01)00380740138479(21)AS1231 (01)00380740138479(21)AS1233 (01)00380740138479(21)AS1234 (01)00380740138479(21)AS1235 (01)00380740138479(21)AS1236 (01)00380740138479(21)AS1237 (01)00380740138479(21)AS1238 (01)00380740138479(21)AS1240 (01)00380740138479(21)AS1241 (01)00380740138479(21)AS1242 (01)00380740138479(21)AS1243 (01)00380740138479(21)AS1246 (01)00380740138479(21)AS1247 (01)00380740138479(21)AS1248 (01)00380740138479(21)AS1249 (01)00380740138479(21)AS1250 (01)00380740138479(21)AS1251 (01)00380740138479(21)AS1252 (01)00380740138479(21)AS1253 (01)00380740138479(21)AS1254 (01)00380740138479(21)AS1255 (01)00380740138479(21)AS1256 (01)00380740138479(21)AS1257 (01)00380740138479(21)AS1259 (01)00380740138479(21)AS1261 (01)00380740138479(21)AS1262 (01)00380740138479(21)AS1263 (01)00380740138479(21)AS1264 (01)00380740138479(21)AS1266 (01)00380740138479(21)AS1267 (01)00380740138479(21)AS1268 (01)00380740138479(21)AS1269 (01)00380740138479(21)AS1270 (01)00380740138479(21)AS1271 (01)00380740138479(21)AS1272 (01)00380740138479(21)AS1273 (01)00380740138479(21)AS1274 (01)00380740138479(21)AS1275 (01)00380740138479(21)AS1276 (01)00380740138479(21)AS1277 (01)00380740138479(21)AS1278 (01)00380740138479(21)AS1279 (01)00380740138479(21)AS1280 (01)00380740138479(21)AS1281 (01)00380740138479(21)AS1282 (01)00380740138479(21)AS1283 (01)00380740138479(21)AS1284 (01)00380740138479(21)AS1285 (01)00380740138479(21)AS1286 (01)00380740138479(21)AS1287 (01)00380740138479(21)AS1288 (01)00380740138479(21)AS1289 (01)00380740138479(21)AS1290 (01)00380740138479(21)AS1291 (01)00380740138479(21)AS1293 (01)00380740138479(21)AS1294 (01)00380740138479(21)AS1295 (01)00380740138479(21)AS1296 (01)00380740138479(21)AS1299 (01)00380740138479(21)AS1300 (01)00380740138479(21)AS1301 (01)00380740138479(21)AS1302 (01)00380740138479(21)AS1303 (01)00380740138479(21)AS1304 (01)00380740138479(21)AS1305 (01)00380740138479(21)AS1306 (01)00380740138479(21)AS1307 (01)00380740138479(21)AS1309 (01)00380740138479(21)AS1310 (01)00380740138479(21)AS1311 (01)00380740138479(21)AS1312 (01)00380740138479(21)AS1313 (01)00380740138479(21)AS1314 (01)00380740138479(21)AS1315 (01)00380740138479(21)AS1316 (01)00380740138479(21)AS1317 (01)00380740138479(21)AS1318 (01)00380740138479(21)AS1319 (01)00380740138479(21)AS1320 (01)00380740138479(21)AS1321 (01)00380740138479(21)AS1322 (01)00380740138479(21)AS1323 (01)00380740138479(21)AS1325 (01)00380740138479(21)AS1326 (01)00380740138479(21)AS1327 (01)00380740138479(21)AS1330 (01)00380740138479(21)AS1332 (01)00380740138479(21)AS1333 (01)00380740138479(21)AS1334 (01)00380740138479(21)AS1336 (01)00380740138479(21)AS1341 (01)00380740138479(21)AS1344 (01)00380740138479(21)AS1346 (01)00380740138479(21)AS1347 (01)00380740138479(21)AS1348 (01)00380740138479(21)AS1349 (01)00380740138479(21)AS1350 (01)00380740138479(21)AS1351 (01)00380740138479(21)AS1352 (01)00380740138479(21)AS1353 (01)00380740138479(21)AS1354 (01)00380740138479(21)AS1355 (01)00380740138479(21)AS1358 (01)00380740138479(21)AS1359 (01)00380740138479(21)AS1360 (01)00380740138479(21)AS1368

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0749-2022
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources