Immunalysis recalls EDDP Urine Control Set 1 due to potential inaccurate test results. The High control may produce values below 100 ng/mL when used in clinical analyzers, which could lead to false negative results.
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.
Immunalysis is recalling its EDDP Urine Control Set 1 because the High (125 ng/ml) control may produce values below 100 ng/mL when tested on clinical analyzers. This could cause false negative results in urine tests for certain substances.
The High control (125 ng/ml) may produce values below 100 ng/mL when run on validated clinical analyzers. This is below the 100 ng/mL cutoff used in the EDDP Specific Urine Enzyme Immunoassay, potentially causing false negative results.
Users of the EDDP Urine Control Set 1 for urine testing are affected. Those using the control in clinical settings may face inaccurate test results.
Check for the EDDP Urine Control Set 1 with Part Number 3006-5 and Lot Number EK16135. This product is used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay.
Verify the Part Number (3006-5) and Lot Number (EK16135) on the product label.
The High (125 ng/ml) control may produce values below 100 ng/mL when tested on clinical analyzers, which is below the required cutoff for the EDDP test.
Using this control could lead to false negative results in urine tests, but it does not pose a direct health risk to users.
Look for the EDDP Urine Control Set 1 with Part Number 3006-5 and Lot Number EK16135.
We’ve drafted a message you can send Immunalysis to request your refund or repair — edit it as you like.
Subject: Recall Z-2140-2018 — Immunalysis Immunalysis Hello, I own a Immunalysis that is covered by recall Z-2140-2018 from Immunalysis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
