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Recall Observatory FDA recall evidence

Device product

Cepheid Xpert C. difficile/Epi Control Panel

Z-1838-2019

May 16, 2019

Class III

Product summary

Firm
Microbiologics Inc
Event
Event 82787
Status
Ongoing
Classification
Class III
Quantity
22 units
Official record key
device-enforcement:Z-1838-2019

Official wording

Reason: Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Code information: UDI: 70845357041370, Lot Number 8200-26

Distribution pattern: NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.