Reported Feb 16, 2022 · Terminated

LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of…

Microbiologics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440

Is this the product you have?

  • 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.
Lot codes and dates
  • Catalog Number0939L
  • Lot Number939-47-1
  • UDI10845357022728
Amount recalled
1 unit

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 22, 2022 · Data as of Sep 19, 7:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.