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Terminated

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.

FDA Recall Z-1196-2019 · Posted None

Recalling FirmAbbott Gmbh & Co. KG
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-02-26
Date Terminated2022-09-28
Product Quantity1097

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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