Microbiologics recalls KWIK-STIK IVD controls with lot 323-108-7 due to incorrect labeling. Affected units may have wrong product code, but no safety risk is reported. Check your lot number for recall.
“Microbiologics KWIK-STIK IVD Controls Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63236-microbiologics-kwik-stik-ivd-controls-recall-incorrect-labeling-risk. Based on FDA recall #Z-0544-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0544-2022%22&limit=1).
The FDA announced on Feb. 24, 2021, that Microbiologics Inc is recalling KWIK-STIK products due to potential mislabeling of packaging pouches. The agency issued recall number Z-0544-2022 for the Class III device.
How to tell if you have it
Brand: Microbiologics
Product: KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047
REF: 0323P
Lot Number: 323-108-7
UDI: 20845357006381
Catalog Number: 0323P
The hazard
According to the FDA, products packaged for lot 323-108-7 were potentially packaged in pouches labeled as 726-57-10. The recall involves 47 packs containing 94 units distributed in the U.S. and internationally.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls of similar products include Microbiologics KWIK-STIK 2-Pack (Dec. 2, 2025), Microbiologics KWIK-STIK Quality Control Kit Recall (Nov. 13, 2025), and Microbiologics LYFO-DISK recall (June 27, 2025). Other recent recalls of similar products include Omnicell i.v.Station Label Stock Recall (March 25, 2026), Medline TRACH TUBE KIT Recall (July 10, 2026), and Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026).
How to tell if you have this one
Check your KWIK-STIK IVD control lot number. The affected lot is 323-108-7. The product is labeled with catalog number 0323P and unique identifier 20845357006381.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number 323-108-7 on your KWIK-STIK IVD control packaging.
Where it went and when
Where it was distributed
Distributed in 10 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Hawaii, Michigan, New Hampshire, New Jersey, North Carolina, Oklahoma, Oregon, Tennessee.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0544-2022 (February 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0544-2022 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.