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U.S. Department of Health and Human Services

Class 2 Device Recall SWIN 2017 database, Model YSW4000

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  Class 2 Device Recall SWIN 2017 database, Model YSW4000 see related information
Date Initiated by Firm January 04, 2019
Create Date May 08, 2020
Recall Status1 Terminated 3 on August 17, 2020
Recall Number Z-1939-2020
Recall Event ID 84764
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product SWIN 2017 database, Model YSW4000
Code Information ...
Recalling Firm/
Remel Inc.
1 Thermo Fisher Way
Oakwood Village OH 44146-6536
For Additional Information Contact
Manufacturer Reason
for Recall
Potential for out of range microbial results
FDA Determined
Cause 2
Software design
Action Technicians replaced YSW514-17 with YSW514-17A.
Quantity in Commerce 250
Distribution ...
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.