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U.S. Department of Health and Human Services

Class 2 Device Recall KWIKSTIK

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 Class 2 Device Recall KWIKSTIKsee related information
Date Initiated by FirmNovember 13, 2025
Date PostedDecember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0876-2026
Recall Event ID 97987
Product Classification Kit, quality control for culture media - Product Code JTR
ProductKWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Code Information UDI-DI: 30845357020018; Lot Number: 818-111-7
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactRebecca Neu
320-229-7080
Manufacturer Reason
for Recall		Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Medical Device Recall notification letter dated 11/13/25 was sent to customers. INSTRUCTIONS: 1.CONTACT END USERS who have received or may have received the affected items above and provide them with the Customer Communication and Customer Response Forms. 2.COMPLETE the Distributor Response Form provided. 3.RETURN the response forms to recall@microbiologics.com. 4.KEEP this letter for your records. 5.CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.
Quantity in Commerce5 units
DistributionInternational distribution to the countries of UAE, China, Singapore, Kazakhstan,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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