Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SPIFE ImmunoFix-6 Kit Recalled by Helena Laboratories, Corp. Due to The plates do not have wells punched for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Helena Laboratories, Corp. directly.
Affected Products
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Quantity: 24 kits
Why Was This Recalled?
The plates do not have wells punched for the controls in the patient 1 area.
Where Was This Sold?
This product was distributed to 7 states: IN, KY, MA, OH, OR, TN, TX
About Helena Laboratories, Corp.
Helena Laboratories, Corp. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report