Microbiologics KWIK-STIK IVD Controls Recall: Labeling Error Risk
Microbiologics recalls KWIK-STIK IVD controls with potential labeling error in lot 726-57-10. Affected units may have incorrect packaging labels.
Lower-risk recall
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Contact the company
What happened, in plain English
Microbiologics is recalling KWIK-STIK IVD controls that were packaged with a labeling error in lot 726-57-10. This error means some units might have the wrong label number, but the product itself is safe to use. Read more at govinfonow.com/recall/63238-microbiologics-kwik-stik-ivd-controls-recall-labeling-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63238-microbiologics-kwik-stik-ivd-controls-recall-labeling-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0543-2022
Cite this page
“Microbiologics KWIK-STIK IVD Controls Recall: Labeling Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63238-microbiologics-kwik-stik-ivd-controls-recall-labeling-error-risk. Based on FDA recall #Z-0543-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2022%22&limit=1).
Why it’s dangerous
The product was packaged with a label number that doesn't match the actual product. This could cause confusion in laboratory settings where precise labeling is critical for proper use and safety.
Who’s affected
Users of KWIK-STIK IVD controls with lot number 726-57-10 are affected. Laboratory personnel handling these products are most at risk due to potential labeling confusion.
How to tell if you have this one
Check for the lot number 726-57-10 on the packaging. The product is labeled as KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P.
- Brand
Microbiologics- Category
Medical device
What to do — step by step
Check Product Label
Look for the lot number 726-57-10 on the packaging to identify affected units.
Where it went and when
Where it was distributed
Distributed in 10 states, and outside the U.S.
FDA distribution: “Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Mississippi, Montana, Nevada, New Mexico, North Carolina, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0543-2022 (February 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0543-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.