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 AIA360 Automated Immunoassay Analyzer

  • 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 AIA360 Automated Immunoassay Analyzersee related information
Date Initiated by FirmJanuary 10, 2020
Date PostedFebruary 11, 2020
Recall Status1 Terminated 3 on September 10, 2020
Recall NumberZ-1420-2020
Recall Event ID 84787
Product Classification Fluorometer, for clinical use - Product Code KHO
ProductAIA-360 Automated Immunoassay Analyzer, Product Code 019945
Code Information 28469102 28629205 28469202 28629305 28469302 28629405 28469402 28629505 28469502 28629605 28469602 28629705 28469702 28709907 28469802 28719007 28469902 28719107 28479002 28719207 28519303 28719307 28519403 28719407 28519503 28719507 28519603 28719607 28519703 28719707 28519803 28719807 28519903 28719907 28529003 28729007 28529103 28729108 28529203 28729208 28529903 28729308 28539003 28729408 28539103 28729508 28539203 28729608 28539303 28759908 28539403 28769008 28539503 28769108 28539603 28769208 28539703 28769308 28539803 28769408
FEI Number 3005529799
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information ContactBernadette O'Connell
800-248-6764
Manufacturer Reason
for Recall		A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.
FDA Determined
Cause 2		Software design
ActionThe firm distributed Urgent Medical Device Correction letters to customers on January 10, 2020. Customers were instructed to retrain from touching the display panel while the analyzer is running. If the analyzer stops and/or the display freezes, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. If your analyzer's serial number is listed among the recalled units, you will be contacted by a Tosoh Field Service Engineer to schedule a visit to replace the display screen which will correct the potential issue. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in Commerce12
DistributionDistributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
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.
-
-