Has DFI Co., Ltd. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to DFI Co., Ltd., including 7 recalls and 0 warning letters.

Recall Record: Class II Recall: One Step K in vitro diagnostic test REF:… by DFI Co., Ltd.

At a glance: DFI Co., Ltd. recalled One Step K in vitro diagnostic test REF: 81A4 on 2026-05-13. FDA classified this action as a Class II recall (recall number Z-2087-2026). Reason for recall: The devices were distributed without required FDA premarket clearance or approval.. Recall status: Ongoing. This is a device-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Key facts

Recalling firm	DFI Co., Ltd.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	One Step K in vitro diagnostic test REF: 81A4
Classification	Class II
Recall number	Z-2087-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	The devices were distributed without required FDA premarket clearance or approval.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is DFI Co., Ltd. and the affected product is described in FDA's record as: One Step K in vitro diagnostic test REF: 81A4. FDA's stated reason for the recall is: The devices were distributed without required FDA premarket clearance or approval.. The recall is tracked under FDA recall number Z-2087-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- One Step K in vitro diagnostic test REF: 81A4 -- and the recall number Z-2087-2026. If it matches, stop using or distributing it and contact DFI Co., Ltd. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

DFI Co., Ltd.’s FDA history

Argus HQ has recorded 7 total FDA actions tied to DFI Co., Ltd.: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (One Step K in vitro diagnostic test REF: 81A4) and recall number Z-2087-2026, then follow DFI Co., Ltd.'s recall instructions.
Has DFI Co., Ltd. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to DFI Co., Ltd., including 7 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2087-2026.

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Full FDA history for DFI Co., Ltd.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: One Step K in vitro diagnostic test REF:… by DFI Co., Ltd.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-dfi-co-ltd-z-2087-2026

MLA

"Recall Record: Class II Recall: One Step K in vitro diagnostic test REF:… by DFI Co., Ltd.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-dfi-co-ltd-z-2087-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: One Step K in vitro diagnostic test REF:… by DFI Co., Ltd.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-dfi-co-ltd-z-2087-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_dfi_co_ltd_z_2087_2026_2026,
  title = {Recall Record: Class II Recall: One Step K in vitro diagnostic test REF:… by DFI Co., Ltd.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-dfi-co-ltd-z-2087-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗