Microbiologics Inc Recall 89412
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.
Microbiologics Inc Recall 89412 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0637-2022 |
| Event ID | 89412 |
| Event 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. |
| Product Type | Devices |
| Distribution | International distribution in the countries of Canada and Germany. |
| Quantity | 1 unit |
| Recall Reason | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. |
| Device Classification | 20220216 |
| Device Code Info | Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728 |
| Center Classification Date | 20220210 |
| Recall Initiation Date | 20170302 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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