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Recall

Class II — Microbiologics Inc

Recalling firmMicrobiologics, Inc.
Registered facilityMicrobiologics, Inc. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonAffected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
ProductKWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Quantity21 total
DistributionUS distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Initiated2025-06-17
Classified2025-07-17
Recall numberZ-2124-2025
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-2124-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97096/

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