Lower riskMedical device recall · FDA · Published April 6, 2022
Helena V8 Immunodisplacement Kit Recall: Microbial Growth Causes Interpretation Errors
Helena Laboratories recalls V8 Immunodisplacement Kit REF 1803 due to microbial growth interfering with test results. Affected units have specific model and lot numbers.
“Helena V8 Immunodisplacement Kit Recall: Microbial Growth Causes Interpretation Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60837-helena-v8-immunodisplacement-kit-recall-microbial-growth-causes-interpretation-errors. Based on FDA recall #Z-1244-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1244-2022%22&limit=1).
The Food and Drug Administration announced on April 6, 2022, that Helena Laboratories, Corp. is recalling V8 Immunodisplacement Kit REF 1803 due to microbial growth causing interference with interpretation. The FDA said the recall is voluntary and ongoing.
Distribution: U.S. (FL, MO, OH, TX) and O.U.S. (Canada, Uruguay, Vietnam)
The hazard
According to the FDA, the hazard is microbial growth causing interference with interpretation.
Context
GovInfoNow's records show Helena Laboratories, Corp. has 8 other recalls on record since July 21, 2017. Other recent recalls of similar products include Instrumentation Laboratory Coagulation Test Kits Risk Microbial Contamination (Dec. 11, 2025), Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (Jan. 7, 2026), and Oxoid Listeria Kits May Give Incorrect Results - Recall (March 3, 2026).
How to tell if you have this one
Check for model number 1803 and lot numbers 3-21-1803 or 1-22-1803. The kit was sold with specific UDI codes starting with M52518030.
Brand
Helena Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the model number (1803) and lot numbers (3-21-1803 or 1-22-1803) to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Missouri, Ohio, Texas.
Recall timeline
FDA published this recall 2 months 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-1244-2022 (April 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1244-2022 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.