KWIK-STIK Enterobacter Cloacae (Microbiologics) – Packaging Error (2021)
Mislabeled packaging can potentially cause procedural confusion in laboratory settings.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Products Sold
Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Microbiologics Inc is recalling KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units due to Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, HI, MI, NH, NJ, NC, OK, OR, TN
Page updated: Jan 10, 2026