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Recall Observatory FDA recall evidence

Device product

ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

Z-2257-2021

July 01, 2021

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 88261
Status
Terminated
Classification
Class II
Quantity
544 units
Official record key
device-enforcement:Z-2257-2021

Official wording

Reason: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

Code information: All Lots

Distribution pattern: US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .