Recall Z-2140-2018— Alere San Diego Inc. DBA Immunalysis Corporation

Name: FDA recall Z-2140-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-28

Class III · Terminated

Class III FDA medical device recall by Alere San Diego Inc. DBA Immunalysis Corporation, initiated 2017-11-28, terminated 2021-01-29. It names one FDA 510(k) clearance: K151395. 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: 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..

Recalling firm: Alere San Diego Inc. DBA Immunalysis Corporation
Classification: Class III
Status: Terminated
Initiated: 2017-11-28
Terminated: 2021-01-29
Firm location: Pomona, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsImmunalysis Corporation·cleared 2015-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.