Recall Z-1497-2019— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2019-04-05, terminated 2022-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-05
- Terminated
- 2022-09-28
- Firm location
- Wiesbaden, N/A, Germany
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.