Alere San Diego Inc. DBA Immunalysis Corporation recalls lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control mate…

Recall date

November 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2140-2018

FDA classification

Class III

Brand / firm

Alere San Diego Inc. DBA Immunalysis Corporation

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.