Recall Z-0789-2019— Abbott Gmbh & Co. KG

Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2018-12-20, terminated 2022-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 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: Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed..

Recalling firm

Abbott Gmbh & Co. KG

Classification

Class II

Status

Terminated

Initiated

2018-12-20

Terminated

2022-09-19

Firm location

Wiesbaden, N/A, Germany

Data sourced from openFDA. This site is unofficial and independent of the FDA.