{ "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": "176487", "product_res_number": "Z-0544-2020", "event_date_initiated": "2019-09-16", "event_date_created": "2019-11-22", "recall_status": "Open, Classified", "res_event_number": "83847", "product_code": "JJE", "product_description": "Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution", "code_info": "List Number 03R66 03, All Serial Numbers", "firm_fei_number": "3002809144", "recalling_firm": "Abbott Gmbh & Co. KG", "address_1": "Max-Planck-Ring 2 2 max-planck-ring", "city": "Wiesbaden", "postal_code": "65205", "country": "Germany", "additional_info_contact": "Albert Chianello\n877-422-2688", "reason_for_recall": "Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.", "root_cause_description": "Device Design", "action": "Abbott GmbH & Co. KG notified customers on about 09/16/2019, via \"Product Correction Urgent Immediate Action Required\" letter. Customers were informed that the development of environmental stress on the bulk solution level sensor can cause cracks. Cracks can allow air to enter the fluid line, which may result either a failure to dispense or an incomplete dispense of the bulk solution on Alinity i and Alinity c. \n\nInstructions included that if using Alinity i, and you receive one of the following\nmessage codes: 1043, 1044, 1072, 1402, 1403. Refer to Appendix B in the letter. If using Alinity c, and you receive one of the following message codes: 3687, 3689. Refer to Appendix B in the letter. For both Alinity i and c, and those \"if\" scenarios occur, then discontinue reporting results until troubleshooting is complete and inspect the Alinity ciseries bulk solution level sensors per the instructions in Appendix A in the letter. If a bulk solution level sensor is found to be cracked: Replace the part before running the system using the replacement instructions found in the Alinity ciseries Operations Manual and Abbott recommends following your laboratory\nprocedure to review results produced since your last successful Quality Control (QC). Last, if the level sensor is not cracked, refer to the Alinity ciseries\nOperations Manual to troubleshoot for the specific message code. \n\nTo assist in the detection of a cracked bulk solution level sensor, Abbott recommends running Quality Control (QC) immediately before performing weekly maintenance. \n\nIf your laboratory had previously identified cracks on the bulk solution level sensor before receipt of this communication, and there are messages associated with patient results in the Alinity ciseries System Logs during the same time period, Abbott recommends following your laboratory procedure to review results produced from the replacement of the bulk solution level sensor to the previous successful Quality Co", "product_quantity": "3,271 units", "distribution_pattern": "Nationwide distribution to AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OK, PR, SC, SD, TN, TX, UT, VA, WA, WI. \n\nInternational distribution to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MADAGASCAR, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, VIETNAM.", "openfda": { "k_number": [ "K965240", "K862235", "K872494", "K832584", "K003721", "K800572", "K823762", "K890927", "K051087", "K963539", "K961274", "K961142", "K841916", "K073370", "K833833", "K852133", "K823386", "K882307", "K840883", "K040958", "K974779", "K915106", "K864849", "K780464", "K833448", "K854138", 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