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Unrated Medical device recall · FDA · Published February 25, 2022

Microbiologics Mycoplasma Control Panel Recall: Inadequate Testing Risk

Microbiologics recalls specific lots of Mycoplasma genitalium Control Panel (Inactivated Pellet) due to improper release testing. Affected units may not meet safety standards.

🇺🇸 FDA recall #Z-0784-2022Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling specific lots of their Mycoplasma genitalium Control Panel (Inactivated Pellet) because the product did not undergo proper release testing. This could mean the product may not meet safety standards, though the recall does not specify a risk of injury or harm. Read more at govinfonow.com/recall/61024-microbiologics-mycoplasma-control-panel-recall-inadequate-testing-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61024-microbiologics-mycoplasma-control-panel-recall-inadequate-testing-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0784-2022

Cite this page

“Microbiologics Mycoplasma Control Panel Recall: Inadequate Testing Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61024-microbiologics-mycoplasma-control-panel-recall-inadequate-testing-risk. Based on FDA recall #Z-0784-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0784-2022%22&limit=1).

The FDA announced on Feb. 25, 2022, that Microbiologics Inc voluntarily recalled its Mycoplasma genitalium Control Panel (Inactivated Pellet) because distributed units did not undergo proper release testing, according to the FDA.

How to tell if you have it

  • Brand: Microbiologics
  • Product: Mycoplasma genitalium Control Panel (Inactivated Pellet)
  • Catalog: 8240
  • Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16
  • UDI: 70845357043053

The hazard

The distributed product did not undergo proper release testing, according to the FDA.

Context

GovInfoNow's records show Microbiologics Inc has issued 35 other recalls since June 6, 2017. Recent brand recalls include a Dec. 2, 2025 recall of LYFO DISK for risk of failed microorganism recovery and a Nov. 13, 2025 recall of KWIK-STIK Quality Control Kit due to lot labeling mix-up. Other recent recalls of similar products include GET TESTED Mycoplasma Test Recall (Nov. 3, 2025), GET TESTED Mycotoxin Panel Test Recall (Nov. 3, 2025), and Medline medical procedure kits recalled for potential endotoxin levels (March 19, 2026).

How to tell if you have this one

Check if your product has the catalog number 8240 and lots 8240-08 through 8240-16. The unique device identifier (UDI) is 70845357043053.

  • Brand
    Microbiologics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify your product's catalog number and lot numbers to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 17 states and D.C., and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: not listedCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: yesDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, Texas, Utah, Washington.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Feb 25, 202212. FDA classified it Class II: Mar 14, 202223. Published in FDA’s Enforcement Report: Mar 23, 202234. FDA terminated the recall: Jan 16, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-0784-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0784-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA