RegWardenFDA facility compliance records
Recall

Class III — Microbiologics Inc

Recalling firmMicrobiologics, Inc.
Registered facilityMicrobiologics, Inc. (the firm's only registered facility)
ClassificationClass III
StatusOngoing
ReasonProduct is labeled with expiration date of 2021-10-31, should be 2021-03-31.
ProductCepheid Xpert C. difficile/Epi Control Panel
Quantity22 units
DistributionNY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
Initiated2019-05-16
Classified2019-06-18
Recall numberZ-1838-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — Microbiologics Inc (Z-1838-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82787/

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