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

Z-0749-2022 Class II Ongoing

Recalled by Abbott Laboratories, Inc — Irving, TX

Recall Details

Product Type
Devices
Report Date
March 23, 2022
Initiation Date
February 3, 2022
Termination Date
N/A
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

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