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U.S. Department of Health and Human Services

Class 2 Device Recall Wako TASWako i30

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  Class 2 Device Recall Wako TASWako i30 see related information
Date Initiated by Firm February 18, 2021
Create Date April 13, 2021
Recall Status1 Terminated 3 on February 24, 2022
Recall Number Z-1412-2021
Recall Event ID 87507
510(K)Number K100464  
Product Classification Test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment - Product Code NSF
Product ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Code Information Lot Number: EQ194 Exp. Date: 05/31/2022
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact SAME
617-861-5300
Manufacturer Reason
for Recall		 Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
FDA Determined
Cause 2		 Under Investigation by firm
Action Fujifilm issued Consignee notifications via courier delivery and electronic mail on February 18, 2021. The letter states reason for recall, health risk and action to take: FUJIFILM is recommending that you immediately cease use of any Cavity #2 chips in Lot EQ194 and return the product to FUJIFILM. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken: Upon receipt of the Field Action Verification Form, FUJIFILM will provide replacement chip cassette boxes (each containing 5 x 20 chips) from a different lot. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com, if you have any further questions regarding this field action.
Quantity in Commerce 496 units
Distribution CA, LA, MN, NC, UT, WI
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.
510(K) Database 510(K)s with Product Code = NSF and Original Applicant = WAKO CHEMICALS USA, INC.
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