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directCHECK ACT-LR Whole Blood Quality Control
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MEDICAL DEVICE RECALLMODERATE

directCHECK ACT-LR Whole Blood Quality Control

Accriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.

What to do

Check your inventory for the affected product and contact the manufacturer for updated labeling or replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-2460-2026
Agency
FDA
Firm
Accriva Diagnostics, Inc.
Recall ID
98979
Status
ONGOING

Why it was recalled

Accriva Diagnostics is recalling the directCHECK ACT-LR whole blood quality control, level 2, due to labeling that contains an incorrect performance range. This error could lead to inaccurate quality control results during testing.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

Lot code
A6DLA001
UDI-DI
10711234170373

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Labeling Error recalls

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Editorial summary by Recall Canary · summary updated 2026-06-17 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification