Lower riskMedical device recall · FDA · Published May 27, 2025
Microbiologics KWIK-STICK Quality Control Kit Recall: Wrong Microorganism Risk
Microbiologics recalls KWIK-STICK culture media kits with incorrect microorganism packaging, risking delayed diagnosis. Affected kits have specific catalog numbers and lots.
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.
Take action
Contact the company
📍Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
“Microbiologics KWIK-STICK Quality Control Kit Recall: Wrong Microorganism Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52214-microbiologics-kwik-stick-quality-control-kit-recall-wrong-microorganism-risk. Based on FDA recall #Z-1957-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1957-2025%22&limit=1).
The FDA announced on May 27, 2025, that Microbiologics Inc is recalling KWIK-STICK quality control kits due to incorrect assembly containing the wrong microorganism. This error may lead to delayed diagnosis.
How to tell if you have it
Brand: Microbiologics
Product: KWIK-STICK, Quality control kit for culture media
Catalog Numbers: 01065K, Oligella urethralis derived from ATCC¿; 0621K, Staphylococcus aureus derived from NCTC 12493
Lot Codes: 1065-25-51 (for 01065K); 621-73-21 (for 0621K)
Units affected: 3 total
The hazard
Affected products were packaged with the incorrect KWIK STIK assembly, resulting in the product containing the wrong microorganism. Specifically, catalog number 0621K was packaged with 01065K swabs, and 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since 2017-06-06. Other recent recalls of similar products include a Microbiologics LYFO DISK recall (2025-12-02) and a Microbiologics KWIK-STIK Quality Control Kit Recall (2025-11-13). Medline Convenience Kits recalls occurred on 2026-08-11 and 2026-06-12, followed by a Medline Blood Culture Kit Recall on 2025-12-24.
How to tell if you have this one
Check for catalog numbers 01065K (lot 1065-25-51) or 0621K (lot 621-73-21) on the product packaging.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for catalog numbers 01065K (lot 1065-25-51) or 0621K (lot 621-73-21) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Pennsylvania.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1957-2025 (May 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1957-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.