Fujifilm Medical Systems recalls specific Wako TASWako i30 Chip Cassette units that may cause incorrect DCP and AFP-L3% measurements when used for certain tests.
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Fujifilm Medical Systems is recalling specific Wako TASWako i30 Chip Cassette units that could produce incorrect DCP and AFP-L3% test results. This affects medical devices used for certain diagnostic measurements.
Defective chip cassettes can produce incorrect DCP (disease-specific) and AFP-L3% (liver cancer marker) measurements when used in the Wako TASWako i30 kit. This may lead to misdiagnosis if the results are relied upon.
Healthcare providers using the Wako TASWako i30 kit with the recalled chip cassettes are affected. Patients receiving tests using these cassettes may have inaccurate results.
The recalled cassettes have Lot Number EQ194 and expire May 31, 2022. They are part of the Wako TASWako i30 kit for medical testing.
Look for Lot Number EQ194 on the cassette packaging or label.
Fujifilm Medical Systems recalls Wako TASWako i30 Chip Cassettes with Lot Number EQ194 that expire May 31, 2022 due to potential incorrect DCP and AFP-L3% test results.
Check if your cassette has Lot Number EQ194 and expires May 31, 2022. These are part of the Wako TASWako i30 kit.
The recall record does not specify a remedy, so contact Fujifilm Medical Systems for guidance.
We’ve drafted a message you can send Fujifilm Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1412-2021 — Fujifilm Medical Systems Fujifilm Medical Systems Hello, I own a Fujifilm Medical Systems that is covered by recall Z-1412-2021 from Fujifilm Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
