FDA Medical Device Recalls (openFDA)
Microbiologics Inc: Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
- Recall number
- Z-0302-2021
- Recalling firm
- Microbiologics Inc
- Product
- Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
- Status
- Terminated
- Initiated
- 2020-10-08
- Posted
- not on file
- Terminated
- 2022-11-17
- Reason
- KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm is sending consignees recall notification letters beginning 10/08/2020 via email. The correction communication was first extended to the first level of the distribution change (those who received product directly from Microbiologics). Distributors outside of the US will be contacted via email, and if follow up is necessary, the recalling firm's international sales team will work with each distributor to ensure this communication is extended to their end users. The recalling firm is working with its European Authorized Representative to coordinate this field safety corrective action in the EU.
- Quantity
- 30 units
- Distribution
- Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
- Lot, serial or model codes
- Catalog 01145P, Lots 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, 1145-07-1 UDI: UDI: 20845357036807
- 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