Recall Z-0637-2022 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
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.
| Date | Mar 2, 2017 |
| Status | Terminated |
| Reason | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. |
| Root cause | Labeling False and Misleading |
| 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 tsobania@microbiol |
| Quantity | 1 unit |
| Distribution | International distribution in the countries of Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS Micro-Bio-Logics, Apr 4, 1986 |