KWIK-STIK recallZ-1957-2025 · Microbiologics Inc · initiated May 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Mixed-up of materials/components
What the company is doing
On 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.
Recall details
- Recall number
- Z-1957-2025
- Status
- Open, Classified
- Initiated by the company
- May 27, 2025
- Posted by the FDA
- Jun 11, 2025
- Recalling firm
- Microbiologics Inc
- Quantity
- 3 total
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
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
Code information (models, lots, serial numbers)
01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 0621UMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- KWIK-STIK™ 01065UMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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