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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity m System

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  Class 2 Device Recall Alinity m System see related information
Date Initiated by Firm December 06, 2021
Create Date January 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-0461-2022
Recall Event ID 89167
Product Classification Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus - Product Code MZP
Product Alinity m System, Part No. 08N53-002
Code Information Alinity m System, Model 08N53-002, all serial numbers
Recalling Firm/
Manufacturer		 Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ray Bastian
224-361-7619
Manufacturer Reason
for Recall		 There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
FDA Determined
Cause 2		 Software design
Action On December 06, 2021 Abbott Molecular issued an attached Product Correction letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative assesses and/or corrects the board values on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
Quantity in Commerce 742 devices
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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