Recall Z-0637-2022
Microbiologics Inc · initiated March 2, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728
Reason for recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
FDA-determined cause: Labeling False and Misleading
Action taken
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 tsobania@microbiolgics.com or by faxing to 320.253.6250.
Details
- Recall number
- Z-0637-2022
- Initiated
- March 2, 2017
- Terminated
- April 22, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 1 unit
- Distribution
- International distribution in the countries of Canada and Germany.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0636-2022 Class III | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit…Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | 03/02/2017Terminated |