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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity i Processing Module

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 Class 2 Device Recall Alinity i Processing Modulesee related information
Date Initiated by FirmDecember 20, 2018
Create DateJanuary 30, 2019
Recall Status1 Terminated 3 on September 19, 2022
Recall NumberZ-0789-2019
Recall Event ID 81916
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductAlinity 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.
Code Information (a) Serial Numbers: Ai01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers
FEI Number 3002809144
Recalling Firm/
Manufacturer		 Abbott Gmbh & Co. KG
Max-planck-ring 2
65205
Wiesbaden Germany
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe 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.
Quantity in Commerce434 units
DistributionWorldwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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