KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17
Summary
The FDA issued a Class II for KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, O by Microbiologics Inc. Reason: Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged .
Details
Source
Device Recall
External ID
Z-1957-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Lot/Code Info: 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21
Quantity Affected: 3 total
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.
Distribution
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-27
Company
Saint Cloud, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1957-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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