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U.S. Department of Health and Human Services

Class 2 Device Recall AIA360

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  Class 2 Device Recall AIA360 see related information
Date Initiated by Firm August 23, 2018
Create Date December 06, 2018
Recall Status1 Terminated 3 on October 20, 2020
Recall Number Z-0559-2019
Recall Event ID 81054
Product Classification Fluorometer, for clinical use - Product Code KHO
Product AIA-360 Analyzer, product code 019945/019945R

The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
Code Information Change to labeling affects all devices.
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Ms. Bernadette O'Connell
800-248-6764
Manufacturer Reason
for Recall		 The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.
FDA Determined
Cause 2		 Labeling Change Control
Action On August 23, 2018, the firm, Tosoh Bioscience, notified affected distributors and customers via "URGENT: MEDICAL DEVICE RECALL" letter. The described the product, problem and actions to be taken. Summary and location of labeling changes: ¿- Elimination of monthly B/F probe maintenance. ¿- Added requirement for use of 70% Ethanol. ¿- Added requirement for use of CAP Class l reagent grade water per CLSI Guidelines and Standards. ¿- Added clarification of substrate stability. Substrate, when stored at 2-8¿C between uses is stable for 30 days. Customers were asked to do the following: -Discontinue maintenance activities on the B/F probe. If issues with the B/F probe are observed, call Technical Support for assistance. ¿- Please continue to perform all your other maintenance procedures at the required intervals as per the instructions in the Operators Manual. ¿- Discard the Training DVD, it is now obsolete. An updated version of the Training DVD, QRG and Training Manual will be sent to you in a separate mailing. ¿- At daily shutdown, use 70% Ethanol to replace the substrate solution. ¿- Use only CAP Class l reagent grade water. ¿- Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. ¿- Maintain this notification with your laboratory records and forward this information to others who may have received this product. ¿- If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of these products, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please contact call (800) 248-6764 or email at bernadette.oconnell@tosoh.com Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in Commerce 1228
Distribution Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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