FDAClass IIIFebruary 16, 2022

LYSO Disk(TM) labeled as containing Actinomyces recall

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

Why was LYSO Disk(TM) labeled as containing Actinomyces recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728

Product
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain…
Recalling firm
Microbiologics Inc
Quantity
1 unit
Distribution
International distribution in the countries of Canada and Germany.
Recall date
February 16, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls