{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192038",
      "product_res_number": "Z-0749-2022",
      "event_date_initiated": "2022-02-03",
      "event_date_created": "2022-03-11",
      "recall_status": "Open, Classified",
      "res_event_number": "89604",
      "product_code": "MZA",
      "product_description": "Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479\n\nThe 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_info": "Serial numbers AS1001 through AS1387\nUDIs:\n(01)00380740138479(21)AS1002\n(01)00380740138479(21)AS1005\n(01)00380740138479(21)AS1009\n(01)00380740138479(21)AS1012 \n(01)00380740138479(21)AS1013 \n(01)00380740138479(21)AS1016 \n(01)00380740138479(21)AS1019 \n(01)00380740138479(21)AS1023 \n(01)00380740138479(21)AS1028 \n(01)00380740138479(21)AS1031 \n(01)00380740138479(21)AS1032 \n(01)00380740138479(21)AS1044 \n(01)00380740138479(21)AS1058 \n(01)00380740138479(21)AS1064 \n(01)00380740138479(21)AS1097 \n(01)00380740138479(21)AS1126 \n(01)00380740138479(21)AS1148 \n(01)00380740138479(21)AS1153 \n(01)00380740138479(21)AS1155 \n(01)00380740138479(21)AS1160 \n(01)00380740138479(21)AS1161 \n(01)00380740138479(21)AS1193 \n(01)00380740138479(21)AS1212 \n(01)00380740138479(21)AS1213 \n(01)00380740138479(21)AS1215 \n(01)00380740138479(21)AS1217 \n(01)00380740138479(21)AS1218 \n(01)00380740138479(21)AS1219 \n(01)00380740138479(21)AS1220 \n(01)00380740138479(21)AS1221 \n(01)00380740138479(21)AS1222 \n(01)00380740138479(21)AS1224 \n(01)00380740138479(21)AS1225 \n(01)00380740138479(21)AS1226 \n(01)00380740138479(21)AS1227 \n(01)00380740138479(21)AS1230 \n(01)00380740138479(21)AS1231 \n(01)00380740138479(21)AS1233 \n(01)00380740138479(21)AS1234 \n(01)00380740138479(21)AS1235 \n(01)00380740138479(21)AS1236 \n(01)00380740138479(21)AS1237 \n(01)00380740138479(21)AS1238 \n(01)00380740138479(21)AS1240 \n(01)00380740138479(21)AS1241\n(01)00380740138479(21)AS1242 \n(01)00380740138479(21)AS1243 \n(01)00380740138479(21)AS1246 \n(01)00380740138479(21)AS1247 \n(01)00380740138479(21)AS1248 \n(01)00380740138479(21)AS1249 \n(01)00380740138479(21)AS1250 \n(01)00380740138479(21)AS1251 \n(01)00380740138479(21)AS1252 \n(01)00380740138479(21)AS1253 \n(01)00380740138479(21)AS1254 \n(01)00380740138479(21)AS1255 \n(01)00380740138479(21)AS1256 \n(01)00380740138479(21)AS1257 \n(01)00380740138479(21)AS1259 \n(01)00380740138479(21)AS1261 \n(01)00380740138479(21)AS1262 \n(01)00380740138479(21)AS1263 \n(01)00380740138479(21)AS1264 \n(01)00380740138479(21)AS1266 \n(01)00380740138479(21)AS1267 \n(01)00380740138479(21)AS1268 \n(01)00380740138479(21)AS1269 \n(01)00380740138479(21)AS1270 \n(01)00380740138479(21)AS1271 \n(01)00380740138479(21)AS1272 \n(01)00380740138479(21)AS1273 \n(01)00380740138479(21)AS1274 \n(01)00380740138479(21)AS1275 \n(01)00380740138479(21)AS1276 \n(01)00380740138479(21)AS1277 \n(01)00380740138479(21)AS1278 \n(01)00380740138479(21)AS1279 \n(01)00380740138479(21)AS1280 \n(01)00380740138479(21)AS1281 \n(01)00380740138479(21)AS1282 \n(01)00380740138479(21)AS1283 \n(01)00380740138479(21)AS1284 \n(01)00380740138479(21)AS1285 \n(01)00380740138479(21)AS1286 \n(01)00380740138479(21)AS1287 \n(01)00380740138479(21)AS1288 \n(01)00380740138479(21)AS1289 \n(01)00380740138479(21)AS1290 \n(01)00380740138479(21)AS1291 \n(01)00380740138479(21)AS1293 \n(01)00380740138479(21)AS1294 \n(01)00380740138479(21)AS1295 \n(01)00380740138479(21)AS1296 \n(01)00380740138479(21)AS1299 \n(01)00380740138479(21)AS1300 \n(01)00380740138479(21)AS1301 \n(01)00380740138479(21)AS1302 \n(01)00380740138479(21)AS1303 \n(01)00380740138479(21)AS1304 \n(01)00380740138479(21)AS1305 \n(01)00380740138479(21)AS1306 \n(01)00380740138479(21)AS1307 \n(01)00380740138479(21)AS1309 \n(01)00380740138479(21)AS1310 \n(01)00380740138479(21)AS1311 \n(01)00380740138479(21)AS1312 \n(01)00380740138479(21)AS1313 \n(01)00380740138479(21)AS1314 \n(01)00380740138479(21)AS1315 \n(01)00380740138479(21)AS1316 \n(01)00380740138479(21)AS1317 \n(01)00380740138479(21)AS1318 \n(01)00380740138479(21)AS1319 \n(01)00380740138479(21)AS1320 \n(01)00380740138479(21)AS1321 \n(01)00380740138479(21)AS1322 \n(01)00380740138479(21)AS1323 \n(01)00380740138479(21)AS1325 \n(01)00380740138479(21)AS1326 \n(01)00380740138479(21)AS1327 \n(01)00380740138479(21)AS1330 \n(01)00380740138479(21)AS1332 \n(01)00380740138479(21)AS1333 \n(01)00380740138479(21)AS1334 \n(01)00380740138479(21)AS1336 \n(01)00380740138479(21)AS1341 \n(01)00380740138479(21)AS1344 \n(01)00380740138479(21)AS1346 \n(01)00380740138479(21)AS1347 \n(01)00380740138479(21)AS1348 \n(01)00380740138479(21)AS1349 \n(01)00380740138479(21)AS1350 \n(01)00380740138479(21)AS1351 \n(01)00380740138479(21)AS1352 \n(01)00380740138479(21)AS1353 \n(01)00380740138479(21)AS1354 \n(01)00380740138479(21)AS1355 \n(01)00380740138479(21)AS1358 \n(01)00380740138479(21)AS1359 \n(01)00380740138479(21)AS1360 \n(01)00380740138479(21)AS1368",
      "firm_fei_number": "1628664",
      "recalling_firm": "Abbott Laboratories, Inc",
      "address_1": "1921 Hurd Dr",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038-4313",
      "additional_info_contact": "Suchin Song\n224-668-0343",
      "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.",
      "root_cause_description": "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\n\nPlease 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nPlease 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.\n\nIf you have forwarded the product listed above to other laboratories, please inform them\nof this Product Correction and provide to them a copy of this letter. Please complete and return the Customer Re",
      "product_quantity": "306 units",
      "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.",
      "openfda": {
        "registration_number": [
          "2250051",
          "3006198300",
          "3003559191",
          "1415939",
          "3002809144",
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        ],
        "fei_number": [
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          "1181121",
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          "1000136573",
          "3005333358",
          "3002806559"
        ],
        "device_name": "Test, Equipment, Automated Bloodborne Pathogen",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}