Z-1497-2019Class II

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine...

Name: Z-1497-2019 Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine...
Creator: Abbott Gmbh & Co. KG
Published: 2019-04-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-04-05 / Terminated / root cause: design

FDA source

Abbott Gmbh & Co. KG began a recall of Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER... on 2019-04-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1497-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-05
Posted: 2019-05-30
Terminated: 2022-09-28
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-30

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)