FDA recall Z-2124-2025

Microbiologics Inc · Class II · device

Product

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Reason for recall

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.

Distribution

US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.

Key facts

Status
Ongoing
Initiation date
2025-06-17
Report date
2025-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2025