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 Tosoh Sorter 9tray and Tosoh Sorter 19tray

  • 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 Tosoh Sorter 9tray and Tosoh Sorter 19tray see related information
Date Initiated by Firm June 11, 2017
Create Date January 31, 2018
Recall Status1 Terminated 3 on December 31, 2019
Recall Number Z-0492-2018
Recall Event ID 78776
Product Classification Fluorometer, for clinical use - Product Code KHO
Product Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932.

Product Usage:
The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
Code Information AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402.
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact
614-317-1909
Manufacturer Reason
for Recall		 This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.
Quantity in Commerce 565 total devices U.S.
Distribution Worldwide Distribution - U.S. Nationwide - Latin America
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.
-
-