Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) Recalled by Randox Laboratories Due to The ACTH in Immunoassay Premium and Premium Plus...
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 Randox Laboratories directly.
Affected Products
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Quantity: 199 Kits
Why Was This Recalled?
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Randox Laboratories
Randox Laboratories has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report