FDAApril 5, 2019device
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 pri...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAi-STAT G3+ cartridge; List Number: 03P78-26;2026-04-01
- FDAi-STAT EG7+ cartridge; List Number: 03P76-25;2026-04-01
- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAHeraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
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