[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Microbiologics Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0637-2022 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 02 March 2017 |
| EAN / barcode | 10845357022728 |
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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