FDA DeviceClass IINotable

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

Date: 2026-06-24
Brand: Accriva Diagnostics, Inc.
Category: Medical Device
FDA Class: Class II

Description

Assayed Whole blood control contains labeling with incorrect performance range.

Hazard

Assayed Whole blood control contains labeling with incorrect performance range.

Remedy

6060

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