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Class 2 Device Recall Alinity S |
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| Date Initiated by Firm |
February 03, 2022 |
| Create Date |
March 11, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0749-2022 |
| Recall Event ID |
89604 |
| Product Classification |
Test, equipment, automated bloodborne pathogen - Product Code MZA
|
| 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. |
| 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
|
Recalling Firm/
Manufacturer |
Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
|
| For Additional Information Contact |
Suchin Song
224-668-0343
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On February 3, 2022, Abbott issued two "Urgent Product Correction" notifications. For US customers these notification where delivered by Abbott personnel. For OUS consignees letters were provided by Abbott personnel or by email. During the week of February 25, 2022, an updated letter was provided to US customers containing additional information. In addition to informing consignees about the recall the firm provided the following instructions
Please perform the necessary immediate actions, if utilizing the Alinity s HIV Ag/Ab Combo and Alinity s Anti-HCV II assays while operating on Alinity s System SW version 2.8.0, to continue to use the Alinity s System. These actions mitigate potential impact for false reactive results when using the Alinity s HIV Ag/Ab Combo Reagent kit.
The Alinity s HIV Ag/Ab Combo and Alinity s Anti-HCV II assays are not installed or do not run on the same Alinity s System. - No action is required.
The Alinity s Anti-HCV II assay is not calibrated and run on the same processing lane as the Alinity s HIV Ag/Ab Combo assay. - Maintain the current assay configuration and ensure the Alinity s HIV Ag/Ab Combo assay is not run on the same processing lane as the Alinity s Anti-HCV II assay.
The Alinity s Anti-HCV II assay and the Alinity s HIV Ag/Ab Combo assay are calibrated and run on the same processing lane. - Contact your local area customer service representative to assess the configuration and uninstall/reinstall the assays to run on separate processing lanes or instruments.
Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported Alinity s HIV Ag/Ab Combo assay test results while operating on Alinity s System SW version 2.8.0.
If you have forwarded the product listed above to other laboratories, please inform them
of this Product Correction and provide to them a copy of this letter. Please complete and return the Customer Re |
| Quantity in Commerce |
306 units |
| Distribution |
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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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