Exact FDA event identifier

Event 86550

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

Open FDA event record

Event summary

Timeline bucket: September 25, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Quidel Corporation

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

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Z-0428-2021

Recall number: Z-0428-2021
Initiated: September 25, 2020
Classification: Class II
Status: Terminated
Recalling firm: Quidel Corporation
Quantity: 8,628 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to false positive results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to false positive results.

Code information

Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817

Distribution pattern

U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY