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[Recalled] 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

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductLYSO 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.
Brand / manufacturerMicrobiologics Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0637-2022
Country of noticeUnited States
Risk levelClass III
Hazard typerecall
Notice date02 March 2017
EAN / barcode10845357022728

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Microbiologics Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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