FDA Medical Device Recalls (openFDA)
Microbiologics Inc: KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
- Recall number
- Z-0543-2022
- Recalling firm
- Microbiologics Inc
- Product
- KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
- Status
- Terminated
- Initiated
- 2021-02-24
- Posted
- 2022-01-28
- Terminated
- 2022-07-11
- Reason
- Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
- Root cause
- Labeling mix-ups
- Action
- Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 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. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.
- Quantity
- 65 packs (130 units)
- Distribution
- Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.
- Lot, serial or model codes
- Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486
- 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