The Recall Desk

Manufacturer

AZURE BIOTECH INC

1 recall in our database name AZURE BIOTECH INC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-04-28

Of the 1 recalls from AZURE BIOTECH INC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-1432-2021·2021-04-28

    Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors

    Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.

    Product
    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Tes
    Category
    Medical Device
    Distribution
    Distributed nationwide