Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure
Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a quality control failure in a laboratory reagent rather than a direct patient safety hazard like a defect in a therapeutic device.
Plain-English summary
Immunalysis Corporation is recalling 37 kits of the EDDP Urine Control Set 1 (Part Number 3006-5, Lot Number EK16135). These control materials are used in the ammonolysis EDDP Specific Urine Enzyme Immunoassay to verify the performance of the test system.
The recall was initiated because the High (125 ng/ml) Control does not meet specifications. It has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers. This is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay, which could lead to inaccurate preliminary analytical results.
The affected products were distributed in the United States to the states of California, Colorado, Connecticut, Florida, Louisiana, Maryland, North Carolina, New Jersey, Ohio, Oklahoma, Tennessee, Texas, Wisconsin, and West Virginia. Users should stop using the affected control sets and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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
- Manufacturer
- Alere San Diego Inc. DBA Immunalysis Corporation
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: 3006-5
- Lot Number: EK16135
Distribution
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