PlainRecalls
FDA Devices Moderate Class II Terminated

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER 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 analy

Reported: June 5, 2019 Initiated: April 5, 2019 #Z-1497-2019

Product Description

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER 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

Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.

Details

Recalling Firm
Abbott Gmbh & Co. KG
Units Affected
373 units total
Distribution
Worldwide Distribution - US Nationwide to Oklahoma and Texas. Distributed worldwide to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, MADAGASCAR, MEXICO, NETHERLANDS, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM, VIETNAM.
Location
Wiesbaden, N/A

Frequently Asked Questions

What product was recalled? ▼
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER 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: 373 units total.
Why was this product recalled? ▼
Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Moderate. Recall number: Z-1497-2019.

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