RegWardenFDA facility compliance records
Recall

Class II — Microbiologics Inc

Recalling firmMicrobiologics, Inc.
Registered facilityMicrobiologics, Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonShelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
ProductPneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Quantity13 units
DistributionUS distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
Initiated2022-03-03
Classified2022-03-31
Terminated2024-01-16
Recall numberZ-0844-2022
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 II recall — Microbiologics Inc (Z-0844-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89746/

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