PlainRecalls
FDA Devices Moderate Class II 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.

Reported: April 24, 2019 Initiated: February 26, 2019 #Z-1196-2019

Product Description

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.

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.

Details

Recalling Firm
Abbott Gmbh & Co. KG
Units Affected
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.
Location
Wiesbaden, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Abbott Gmbh & Co. KG. Units affected: 1097.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1196-2019.

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