Abbott Gmbh & Co. KG: 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.

Recall number

Z-1497-2019

Recalling firm

Abbott Gmbh & Co. KG

Product

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.

Status

Terminated

Initiated

2019-04-05

Posted

not on file

Terminated

2022-09-28

Reason

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.

Root cause

Under Investigation by firm

Action

Abbott notified customers on about 04/05/2019 via "Product Correction Urgent - Immediate Action Required" letter. The letter instructed customers to power off their Alinity i System if they experience unexpected reagent supply temperature errors, detect a burning smell or visible smoke. They were also instructed that their Abbott representative will contact them to schedule the replacement of the impacted parts, to forward the Product Correction letter if the device has been further distributed, retain the letter for laboratory records, and complete and return the attached Customer Reply form. Questions can be directed to Customer Service at at 18774ABBOTT (available 24 hours a day, 7 days a week) for US customers. For customers outside the US, they are instructed to contact their local area Customer Service.

Quantity

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.

Lot, serial or model codes

Part Number: 03R65 01, all Serial Numbers;   a. TED (Thermo Electric Device) Engine, Reagent cooler - Part Numbers A 30103732 01, A 30103732 02 with all Serial Numbers;   b. CABLE, POWER OUT, TED CNTRLER - Part Numbers A 35006203 01, A 35006203 02 with all Serial Numbers

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJE

Firm FEI

3002809144

Firm city

Wiesbaden

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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