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Recall

Class III — Microbiologics Inc

Recalling firmMicrobiologics, Inc.
Registered facilityMicrobiologics, Inc. (the firm's only registered facility)
ClassificationClass III
StatusTerminated
ReasonPotential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
ProductKWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Quantity65 packs (130 units)
DistributionWorldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.
Initiated2021-02-24
Classified2022-01-28
Terminated2022-07-11
Recall numberZ-0543-2022
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 III recall — Microbiologics Inc (Z-0543-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89379/

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