LYFO DISK recallZ-0637-2022 · Microbiologics Inc · initiated Mar 2, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
FDA root cause category: Labeling False and Misleading
What the company is doing
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.
Recall details
- Recall number
- Z-0637-2022
- Status
- Terminated
- Initiated by the company
- Mar 2, 2017
- Recalling firm
- Microbiologics Inc
- Quantity
- 1 unit
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- International distribution in the countries of Canada and Germany.
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.
Code information (models, lots, serial numbers)
Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LYFO DISK™ 0939LMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89412).
- Z-0636-2022 · TerminatedKWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fl…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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