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One+Step Protein 8194Recalls & reported problems

Dfi CO.,Ltd · 100strip/1 bottle · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Apr 2, 2026Open, Classified

    The devices were distributed without required FDA premarket clearance or approval.

    Z-2088-2026 · Root cause: No Marketing Application · Recall details · FDA record ↗

Other Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page