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Recall Observatory FDA recall evidence

Device product

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Z-0428-2021

September 25, 2020

Class II

Product summary

Firm
Quidel Corporation
Event
Event 86550
Status
Terminated
Classification
Class II
Quantity
8,628 kits
Official record key
device-enforcement:Z-0428-2021

Official wording

Reason: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to false positive results.