LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellet
Summary
The FDA issued a Class III for LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Di by Microbiologics Inc. Reason: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta..
Details
Source
Device Recall
External ID
Z-0637-2022
Action Date
2022-02-16
Status
Terminated
Category
device
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.
Lot/Code Info: Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728
Quantity Affected: 1 unit
Reason for Recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Distribution
International distribution in the countries of Canada and Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2017-03-02
Company
Saint Cloud, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0637-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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