FDA Medical Device Recalls (openFDA)
Microbiologics Inc: KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Recall number
- Z-2124-2025
- Recalling firm
- Microbiologics Inc
- Product
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Status
- Open, Classified
- Initiated
- 2025-06-17
- Posted
- 2025-07-17
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On June 17. 2025, the firm began notifying affected customers via "Urgent Medical Device Recall" letters delivered through email. Customers were instructed to review lab procedures to understand how the information may affect usage; use or discard product depending on lab procedures. Complete and return the response form to recall@microbiologics.com. If product was further distributed or transferred to other facilities or customers, they should also be notified. Customers may contact Microbiologics if a replacement kit is needed. If you have any questions or concerns, contact Recall Support team at 320.229.7080 or recall@microbiologics.com. Collect calls may be made.
- Quantity
- 21 total
- Distribution
- US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
- Lot, serial or model codes
- Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
- 510(k) numbers
- ["K861022"]
- PMA numbers
- not on file
- Product code
- JTR
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28