LYSO Disk microorganism culture device mislabeled with incorrect strain
Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification with no reported illnesses or injuries. This is a labeling error where the microorganism strain is misidentified, which could affect laboratory testing accuracy but presents no immediate physical harm. Per the rubric, Class III recalls without reported harm and minor labeling errors score as Moderate (2).
Plain-English summary
Microbiologics Inc is recalling LYSO Disk™ microorganism culture disks labeled as containing Actinomyces odontolyticus. Testing revealed that the disks actually contain Eggerthella lenta, a different bacterial strain. Each unit contains six lyophilized pellets in a sealed glass vial with desiccant. The affected product was distributed internationally to Canada and Germany.
The mislabeling presents a risk of incorrect bacterial strain identification and potentially inaccurate laboratory or clinical testing results. Users relying on these disks for bacterial identification or quality control may obtain incorrect results due to the strain misidentification.
Affected lot number 939-47-1 (Catalog Number 0939L, UDI: 10845357022728) should be discontinued from use immediately. Laboratory and clinical users possessing these disks should verify that testing performed with this product is reviewed and confirmed using correctly labeled reference materials.
The recalled product
- 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
- Manufacturer
- Microbiologics Inc
- Hazard
- organism-misidentification
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number: 0939L
- Lot Number: 939-47-1
- UDI: 10845357022728
Distribution
Distribution scope not specified by the agency.
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