lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls — Class III medical device recall Z-2140-2018
Terminated recall by Alere San Diego Inc. DBA Immunalysis Corporation, reported 2018-06-20, distributed in CA, CO, CT, FL, LA, MD, NC, NJ…. The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 n
| Recall number | Z-2140-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego Inc. DBA Immunalysis Corporation, Pomona, CA, United States |
| Recall initiated | 2017-11-28 |
| Classified | 2018-06-08 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2021-01-29 |
| Distributed | CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, WV |
| Quantity | 37 kits |
| Lot numbers | EK16135 |
| Model numbers | 3006-5 |
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 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2140-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.