Reported Jun 5, 2019 · Terminated
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent…
Abbott GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden, N/A · N/A
Is this the product you have?
- 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 UsageThe 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 03R6501, all Serial Numbers — TED (Thermo Electric Device) Engine, Reagent cooler - Part Numbers A 30103732 01, A 30103732 02 with all Serial Numbers — CABLE, POWER OUT, TED CNTRLER - Part Numbers A 35006203 01, A 35006203 02 with all Serial Numbers - Amount recalled
- 373 units total
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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