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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Alinity i

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  Class 2 Device Recall Abbott Alinity i see related information
Date Initiated by Firm February 26, 2019
Create Date April 18, 2019
Recall Status1 Terminated 3 on September 28, 2022
Recall Number Z-1196-2019
Recall Event ID 82511
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
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Recalling Firm/
Manufacturer		 Abbott Gmbh & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
For Additional Information Contact Albert Chianello
877-422-2688
Manufacturer Reason
for Recall		 The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
FDA Determined
Cause 2		 Under Investigation by firm
Action On February 26, 2019, Abbott sent a correction notice to there customers stating to please continue to follow the instructions provided in the Alinity ci series Operations Manual when replacing the bulk solutions. Use caution when accessing bulk solution bottle holders or replacing bulk solution bottles as you may be exposed to a sharp hazard. The Alinity ciseries Operations Manual will be updated in the future to add the appropriate hazard information to the procedure. If the safety interlock or bottle release does not function correctly, please contact your area customer support for assistance. Your Abbott representative will contact you to schedule the placement of hazard labeling in the bulk solution area to increase awareness of this hazard. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Quantity in Commerce 1097
Distribution Worldwide distribution - US Nationwide in the states of AR, CA, GA, ME, MN, MO, NY, OK, SC, TN, TX, UT, and VA, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, LATVIA, LEBANON, MADAGASCAR, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, and VIETNAM.
Total Product Life Cycle TPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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