Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Alinity m system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Alinity m systemsee related information
Date Initiated by FirmDecember 06, 2021
Create DateJanuary 06, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0462-2022
Recall Event ID 89168
Product Classification Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus - Product Code MZP
ProductAlinity 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 ContactRay Bastian
224-361-7619
Manufacturer Reason
for Recall		There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
FDA Determined
Cause 2		Software design
ActionOn December 06, 2021 Abbott Molecular issued a Product Recall 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 adjusts the amplification detection clamp height on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
Quantity in Commerce742 devices
DistributionWorldwide distribution - US distribution 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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-