Microbiologics quality control kits recalled for organism content mismatch
Microbiologics Inc is recalling KWIK-STIK and LYFO DISK quality control kits because they contain the wrong organism, which could cause laboratory quality control to fail and delay patient diagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is scored as High (3) under FDA Class II medical device classification with no reported injuries or illnesses. It qualifies as a risk-of-harm product where injury has not yet been reported, as the incorrect organism could cause laboratory quality control failures and delayed patient diagnosis.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK (Catalog #0805K) and LYFO DISK (Catalog #0805L) quality control kits for culture media because they contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. The incorrect organism may cause users' quality control to fail and result in delayed diagnosis for patients.
The affected lots are #805-234-4 and #805-234-5, representing 21 units total. These were distributed in the United States to Utah and Ohio, and internationally to Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
If you have received these quality control kits with the affected lot numbers, contact Microbiologics Inc immediately.
The recalled product
- Product
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Manufacturer
- Microbiologics Inc
- Hazard
- organism-mismatch
- quality-control-failure
- delayed-diagnosis
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)
- Lot #: 805-234-4
- 805-234-5 UDI: (0805K) 30845357019531
- (0805L) 10845357019544
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03