Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling
Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.
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: This is an FDA Class III device recall with no reported illnesses or injuries. The mislabeling presents a theoretical risk to laboratory identification accuracy but poses no known immediate danger.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK(TM) microorganism reference materials with catalog number 0939P and lot number 939-47-2. These lyophilized microorganism kits are labeled as containing Actinomyces odontolyticus but have been found to actually contain Eggerthella lenta.
This mislabeling poses a risk to laboratory and clinical settings that rely on these reference materials for accurate organism identification and testing. The product is used as a control or reference standard in microbiology labs, and using the wrong organism could compromise testing accuracy and results.
The affected devices were distributed internationally to Canada and Germany. No illnesses or injuries have been reported related to this issue.
Laboratory professionals who have received these KWIK-STIK units should immediately stop using them and contact Microbiologics Inc for a replacement or refund.
The recalled product
- Product
- KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccan
- Manufacturer
- Microbiologics Inc
- Hazard
- mislabeling
- organism-misidentification
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: 0939P
- Lot Number: 939-47-2
- UDI: 20845357022701
Distribution
Distribution scope not specified by the agency.
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