Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0637-2022 — LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.

U.S. FDA — Device Enforcement · United States · 2017-03-02 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0637-2022
Date of alert: 2017-03-02
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Microbiologics Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10845357022728

Reported risk: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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