Exact FDA event identifier

Event 87541

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 02, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AZURE BIOTECH INC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 Test * COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) * For Emergency Use Authorization Only * For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST * /Rapid / Reliable / Simple/ * COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) * For Emergency Use Authorization Only, Box Label - ECOTEST RAPID DIAGNOSTIC TEST * Rapid Reliable Simple * COVID-19 IgG/IgM Rapid Test Device * For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.

Z-1432-2021

Recall number: Z-1432-2021
Initiated: March 02, 2021
Classification: Class II
Status: Terminated
Recalling firm: AZURE BIOTECH INC
Quantity: Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.

Code information

Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada.