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Recall Observatory FDA recall evidence

Device product

Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e

Z-1670-2021

April 14, 2021

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 87738
Status
Terminated
Classification
Class II
Quantity
1,034 units
Official record key
device-enforcement:Z-1670-2021

Official wording

Reason: specimens collected in transport media may result is false negative results when stored in certain conditions.

Code information: All Lots

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Alabama, 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 and the country of New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    specimens collected in transport media may result is false negative results when stored in certain conditions.