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Terminated

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.

FDA Recall Z-0789-2019 · Posted None

Recalling FirmAbbott Gmbh & Co. KG
Recall StatusTerminated
Product CodeJJE
Date Initiated2018-12-20
Date Terminated2022-09-19
Product Quantity434 units

Reason for Recall

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.

Firm Action

The firm initiated the recall by letter on 12/20/2018. The letter identified the affected product, problem and actions to be taken. The units will be serviced in the field. For questions contact Customer Service at 1-877-4ABBOTT. Customers outside the U.S., contact your local area Customer Service.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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