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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 i30see related information
Date Initiated by FirmFebruary 18, 2021
Create DateApril 13, 2021
Recall Status1 Terminated 3 on February 24, 2022
Recall NumberZ-1412-2021
Recall Event ID 87507
510(K)NumberK100464 
Product Classification Test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment - Product Code NSF
ProductTASWako 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 ContactSAME
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
ActionFujifilm 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 Commerce496 units
DistributionCA, LA, MN, NC, UT, WI
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.
510(K) Database510(K)s with Product Code = NSF
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