Quidel Corporation: Medical Device Recall in 2020 - (Recall #: Z-0428-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Product Classification:

Class II

Date Initiated: September 25, 2020

Date Posted: November 18, 2020

Recall Number: Z-0428-2021

Event ID: 86550

Reason for Recall:

Due to false positive results.

Status: Terminated

Product Quantity: 8,628 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated