Z-2670-2011

SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for...

Name: Z-2670-2011 SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for...
Creator: Ameditech Inc
Published: 2011-04-26
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2011-04-26 / Terminated / root cause: manufacturing process

FDA source

Ameditech Inc began a recall of SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and... on 2011-04-26. The reason FDA records is "The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2670-2011
Status: Terminated
Initiated: 2011-04-26
Posted: 2011-06-27
Terminated: 2011-08-11
Recalling firm: Ameditech, Inc.
Product: SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.
Product code: DKZ Enzyme Immunoassay, Amphetamine
Reason for recall: The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ameditech, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter requested the customer to: (1) Cease distribution of the affected lot and provide remaining inventory count to Ameditech. (2) Destroy any remaining inventory of these lots and document destruction per your site requirements. (3) Ensure that all users of the device receive a copy of the Urgent Medical Device Recall letter. A recall verification form was attached to the letter to be completed and returned by the customer via fax at 1-858-677-0243. Any questions about the information contained in the recall notice should be directed to Ameditech at [email protected] or call 858-535-1968.
Quantity in commerce: 6000 test cards (120 kits)
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: 110669 & 100093

Product code DKZ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)