Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-06-24
FDA class
Class II

Why it was recalled

Hazard

Assayed Whole blood control contains labeling with incorrect performance range.

Recommended action

What to do

6060

Product description

Assayed Whole blood control contains labeling with incorrect performance range.

Verify with the official notice →
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