Home / Recalls / Quidel Corporation / Z-0428-2021

Z-0428-2021 Class II Terminated

Recalled by Quidel Corporation — San Diego, CA

Recall Details

Product Type
Devices
Report Date
November 18, 2020
Initiation Date
September 25, 2020
Termination Date
September 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,628 kits

Product Description

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Reason for Recall

Due to false positive results.

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

Code Information

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

Other recalls by Quidel Corporation

  • Z-2545-2025 Class II — QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF (June 17, 2025)
  • Z-1637-2024 Class II — QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests (March 5, 2024)
  • Z-1636-2024 Class II — QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests (March 5, 2024)
  • Z-1086-2024 Class II — The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sa (January 3, 2024)
  • Z-1308-2023 Class II — MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibit (February 1, 2023)
  • Z-2477-2021 Class II — Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyr (August 13, 2021)
  • Z-1928-2021 Class I — Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent (April 27, 2021)
  • Z-0124-2021 Class II — Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a latera (September 17, 2020)
  • Z-1183-2018 Class II — Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer inten (December 15, 2017)
  • Z-2803-2017 Class II — InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is (June 22, 2017)