Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls Recalled by Alere San Diego Inc. DBA Immunalysis Corporation Due to The High (125 ng/ml) Control does not meet...
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 Alere San Diego Inc. DBA Immunalysis Corporation directly.
Affected Products
lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.
Quantity: 37 kits
Why Was This Recalled?
The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.
Where Was This Sold?
This product was distributed to 14 states: CA, CO, CT, FL, LA, MD, NJ, NC, OH, OK, TN, TX, WV, WI
About Alere San Diego Inc. DBA Immunalysis Corporation
Alere San Diego Inc. DBA Immunalysis Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report