Reported Apr 21, 2021 · Terminated

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

Fujifilm Medical Systems U.S.A., Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160

Is this the product you have?

  • ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Lot codes and dates
  • Lot NumberEQ194 Exp
  • Date05/31/2022
Amount recalled
496 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 24, 2022 · Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.