Alere San Diego Inc. DBA Immunalysis Corporation: Medical Device Recalls in 2018

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Alere San Diego Inc. DBA Immunalysis Corporation in 2018. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

2018

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.