CLASS III Device recall · Reported 20 Jun 2018 · FDA Enforcement Report

lmmunalysis Eddp Urine Control Set 1 The Eddp Urine recalled

Alere San Diego is recalling lmmunalysis Eddp Urine Control Set 1 The Eddp Urine Controls (High 125 ng/ml and Low 75, distributed in 14 states. The recall was initiated on 28 Nov 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPart Number: 3006-5, Lot Number: EK16135

Quantity recalled37 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2140-2018
FDA event ID: 80096
Recalling firm: Alere San Diego, Pomona, CA
Classification: Class III
Status: Terminated
Recall initiated: 28 Nov 2017
FDA classified: 8 Jun 2018
Reported: 20 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

28 Nov 2017	Recall initiated by company
8 Jun 2018	Classified by FDA	+192 days
20 Jun 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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

California Colorado Connecticut Florida Louisiana Maryland North Carolina New Jersey Ohio Oklahoma Tennessee Texas Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number: 3006-5, Lot Number: EK16135

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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