DFI recalls One Step 10A diagnostic tests distributed without FDA premarket approval. Affected lots: 241023, 250305, 250415, 250527, 250625, 250905. No remedy specified in official notice.
The devices were distributed without required FDA premarket clearance or approval.
DFI recalls certain One Step 10A in vitro diagnostic tests that were distributed without required FDA premarket clearance. This means the tests could be used without proper safety validation, potentially leading to inaccurate results or health risks if used improperly.
The devices were distributed without required FDA premarket clearance or approval. This means the tests may not meet safety and performance standards, potentially causing inaccurate results that could lead to incorrect medical decisions. Without proper regulatory oversight, the risk of harm from improper use is unclear.
Users of the One Step 10A diagnostic tests with the listed lot numbers are affected. Healthcare providers and labs that purchased these tests without verifying FDA clearance are at higher risk.
Check the lot numbers on the test packaging: 241023, 250305, 250415, 250527, 250625, or 250905. The product is sold under the brand DFI.
Look for the lot numbers 241023, 250305, 250415, 250527, 250625, or 250905 on the test packaging.
The devices were distributed without required FDA premarket clearance or approval.
The official notice does not specify a remedy for affected products.
The recall indicates the tests may not meet safety standards, but the official notice does not describe specific risks or injuries.
We’ve drafted a message you can send DFI to request your refund or repair — edit it as you like.
Subject: Recall Z-2082-2026 — DFI DFI Hello, I own a DFI that is covered by recall Z-2082-2026 from DFI. 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.
