Z-2140-2018Class III

lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as...

Name: Z-2140-2018 lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as...
Creator: Alere San Diego Inc. DBA Immunalysis Corporation
Published: 2017-11-28
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2017-11-28 / Terminated

FDA source

Alere San Diego Inc. DBA Immunalysis Corporation began a recall of 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... on 2017-11-28. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2140-2018
Classification: Class III
Status: Terminated
Initiated: 2017-11-28
Posted: 2018-06-08
Terminated: 2021-01-29
Recalling firm: Alere San Diego, Inc.
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.
Product code: DJR Enzyme Immunoassay, Methadone
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.
FDA root cause: Under Investigation by firm
Action: On November 28, 2017, the firm sent their customer notifications of the recall stating the following: CUSTOMER REQUIRED ACTION 1. If you have product in your possession: " Immediately discontinue use and/or sale of affected product lot and place in quarantine. " Complete the enclose Customer Verification Form, within 10 days, indicating the quantity of product you have discarded or will return to lmmunalysis. " FAX completed Customer Verification Form to 909-482-0850 or scan and email to [email protected] " Upon receipt of your Customer Verification Form, we will initiate shipment of replacement product in the quantity indicated on the form and, if applicable, will contact you to arrange product return. " Return product as directed. 2. If you have no remaining product in your possession: " Complete the enclosed Customer Verification Form, within 10 days, indicating "We do not have any affected product - it has been consumed". " FAX completed Customer Verification Form to 909-482-0850 or scan and email to [email protected] 3. Share this information with your staff and retain this notification as part of your records. Please complete this form and return within 10 days even if you do not have any remaining product. Send form to lmmunalysis at Fax 909-482-0850 or by e-mail to [email protected] For further questions, please call (207) 730-5738.
Quantity in commerce: 37 kits
Distribution: US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
Product codes and lots: Part Number: 3006-5, Lot Number: EK16135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2140-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2140-2018	Class III	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-08

Product code DJR

K151395Class IIImmunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsImmunalysis Corporation / cleared 2015-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)