# FDA recall Z-2140-2018

> **Alere San Diego Inc. DBA Immunalysis Corporation** · Class III · device recall initiated 2017-11-28.

## 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.

## Distribution

US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV

## Key facts

- **Recall number:** Z-2140-2018
- **Recalling firm:** Alere San Diego Inc. DBA Immunalysis Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-28
- **Report date:** 2018-06-20
- **Termination date:** 2021-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pomona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2018

## Citation

> AI Analytics. FDA recall Z-2140-2018. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-2140-2018. Source: US FDA. Licensed CC0.

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