Helena SPIFE ImmunoFix-6 Kit: Missing Control Wells Risk Inaccurate Test Results
Helena Laboratories recalls SPIFE ImmunoFix-6 diagnostic kits with missing control wells that could lead to inaccurate test results. Affected kits have specific lot numbers and expiration dates.
Lower-risk recall
The plates do not have wells punched for the controls in the patient 1 area.
Contact the company
What happened, in plain English
Helena Laboratories is recalling SPIFE ImmunoFix-6 diagnostic kits because the test plates lack wells for patient controls. This could cause inaccurate test results if used without the proper controls. Read more at govinfonow.com/recall/73384-helena-spife-immunofix-6-kit-missing-control-wells-risk-inaccurate.
Source Summary by GovInfoNow · govinfonow.com/recall/73384-helena-spife-immunofix-6-kit-missing-control-wells-risk-inaccurate · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0045-2020
Cite this page
“Helena SPIFE ImmunoFix-6 Kit: Missing Control Wells Risk Inaccurate Test Results.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73384-helena-spife-immunofix-6-kit-missing-control-wells-risk-inaccurate. Based on FDA recall #Z-0045-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2020%22&limit=1).
Why it’s dangerous
The test plates in the recalled kits do not have wells punched for controls in the patient 1 area. This means the test may not run correctly without the necessary controls, potentially leading to inaccurate diagnostic results.
Who’s affected
Healthcare professionals using the SPIFE ImmunoFix-6 kits for in-vitro diagnostics are likely affected. Those who use the kits without verifying the control wells may face inaccurate test results.
How to tell if you have this one
Check for the kit's lot number 35-17-552583 with an expiration date of April 30, 2018. The product label shows the manufacturer as Helena Laboratories, Beaumont, TX.
- Brand
Helena- Category
Medical device
What to do — step by step
Verify Kit Lot Number
Check the kit's lot number to confirm it is 35-17-552583.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Kentucky, Massachusetts, Ohio, Oregon, Tennessee, Texas.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-0045-2020 (July 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0045-2020 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.