Alere San Diego Inc. DBA Immunalysis Corporation: Medical Device Recall in 2018 - (Recall #: Z-2140-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: November 28, 2017

Date Posted: June 20, 2018

Recall Number: Z-2140-2018

Event ID: 80096

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.

Status: Terminated

Product Quantity: 37 kits

Code Information:

Part Number: 3006-5, Lot Number: EK16135

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated