FDA Medical Device Recalls (openFDA)
Microbiologics Inc: KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
- Recall number
- Z-2576-2023
- Recalling firm
- Microbiologics Inc
- Product
- KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
- Status
- Open, Classified
- Initiated
- 2023-08-14
- Posted
- 2023-09-11
- Terminated
- not on file
- Reason
- One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
- Root cause
- Packaging process control
- Action
- Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of MN, PA, TN, TX.
- Lot, serial or model codes
- UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
- 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