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.
Reported: February 16, 2022 Initiated: March 2, 2017 #Z-0637-2022
Product Description
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.
Reason for Recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 1 unit
- Distribution
- International distribution in the countries of Canada and Germany.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was 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 adverse moisture accumulation. A LYFO Disk" catalog number ends in L.. Recalled by Microbiologics Inc. Units affected: 1 unit.
Why was this product recalled? ▼
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Low. Recall number: Z-0637-2022.
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