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U.S. Department of Health and Human Services

Class 2 Device Recall KWIK STIK

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 Class 2 Device Recall KWIK STIKsee related information
Date Initiated by FirmMay 27, 2025
Date PostedJune 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1957-2025
Recall Event ID 96974
510(K)NumberK861022 
Product Classification Kit, quality control for culture media - Product Code JTR
ProductKWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Code Information 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactRebecca Neu
320-253-1640
Manufacturer Reason
for Recall		Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn May 27, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed of the affected products containing the wrong microorganisms. Customers were instructed to review lab procedures to understand how this information affects their usage, and then to use or discard the product depending on the lab procedures and how the issue affects usage. Distributors of the affected product were instructed to contact end users who have received the affected items.
Quantity in Commerce3 total
DistributionUS Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
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.
510(K) Database510(K)s with Product Code = JTR
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