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.
FDA Recall Z-0637-2022 · Posted None
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Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2017-03-02
Date Terminated2022-04-22
Product Quantity1 unit
Reason for Recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Firm Action
Microbiologics notified customers on about 03/02/2017, via letter titled "Medical Device Recall." Customers were instructed to:
1. DO NOT USE any lot number 939-47-1 or 939-47-2 you may have in inventory.
2. QUARANTINE or DISCARD the product to prevent further use.
3. RETURN any remaining inventory you have of this product to Microbiologics via FED-EX though the use of FED-EX account number 355830926, and mark box Attention: Technical Manager.
4. Acknowledge your receipt of this information by completing the attached form and returning to Microbiologics by e-mailing to [email protected] or by faxing to 320.253.6250.
Root Cause
Labeling False and Misleading
Distribution Pattern
International distribution in the countries of Canada and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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