FDA Device recall Z-1497-2019
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler
- FDA Device
- Class II
- terminated
- Published 2019-06-05
On 2019-06-05 the FDA classified a Class II recall of Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler by Abbott And Kg, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1497-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-05 |
| Published | 2019-06-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
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.
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.
Identifiers
| code_info | Part Number: 03R65 01, all Serial Numbers; a. TED (Thermo Electric Device) Engine, Reagent cooler - Part Numbers…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1497-2019%22
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