KWIK-STIK Clostridium (Microbiologics) – Lot Number Error (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213
Products Sold
Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213
Microbiologics Inc is recalling KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) due to The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number mispri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
Recommended Action
Per FDA guidance
Microbiologics notified customers on about 10/08/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following: 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 orrecall@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 noticePage updated: Jan 10, 2026