FDA Medical devices recall ·
KWIK-STIK and LYFO DISK, quality control kit for culture media recall
- Recall number
- Z-2124-2025
- Date
- (initiated June 17, 2025)
- Company / brand
- Microbiologics Inc
200 Cooper Ave N, Saint Cloud, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21 total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Why was it recalled?
Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
Distribution
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2124-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.