medical Class II Updated 2022-03-23

Abbott Laboratories, Inc recalls Alinity s System software version2.8.0, REF LN 06P16-01, IVD

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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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