FDA Medical Device Recalls (openFDA)
Microbiologics Inc: KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
- Recall number
- Z-0984-2026
- Recalling firm
- Microbiologics Inc
- Product
- KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
- Status
- Open, Classified
- Initiated
- 2025-12-02
- Posted
- 2025-12-22
- Terminated
- not on file
- Reason
- Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Recall notification letter was sent to customers on 12/2/25. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage. 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com. 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team An Urgent Medical Device Recall dated 12/22/25 was sent to customers. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage. 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com. 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.
- Quantity
- 86 units (127 additional units 12/22/25)
- Distribution
- Worldwide - US Nationwide.
- Lot, serial or model codes
- UDI-DI: 20845357006459; Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5
- 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