Fujifilm Wako TASWako i30 Chip Cassette Recall: Incorrect DCP/AFP-L3% Values
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.
Lower-risk recall
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63262-fujifilm-wako-taswako-i30-chip-cassette-recall-incorrect-dcp-afp.
Source Summary by GovInfoNow · govinfonow.com/recall/63262-fujifilm-wako-taswako-i30-chip-cassette-recall-incorrect-dcp-afp · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1412-2021
Cite this page
“Fujifilm Wako TASWako i30 Chip Cassette Recall: Incorrect DCP/AFP-L3% Values.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63262-fujifilm-wako-taswako-i30-chip-cassette-recall-incorrect-dcp-afp. Based on FDA recall #Z-1412-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1412-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
The recalled cassettes have Lot Number EQ194 and expire May 31, 2022. They are part of the Wako TASWako i30 kit for medical testing.
- Brand
Fujifilm Medical Systems- Category
Medical device
What to do — step by step
Check Cassette Lot Number
Look for Lot Number EQ194 on the cassette packaging or label.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “CA, LA, MN, NC, UT, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Louisiana, Minnesota, North Carolina, Utah, Wisconsin.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1412-2021 (February 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1412-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.