FDAClass IIApril 21, 2021

¿TASWako Chip Cassette is recall

¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

Why was ¿TASWako Chip Cassette is recalled?

Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: EQ194 Exp. Date: 05/31/2022

Product
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Recalling firm
Fujifilm Medical Systems U.S.A., Inc.
Quantity
496 units
Distribution
CA, LA, MN, NC, UT, WI
Recall date
April 21, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls