Recall Z-2670-2011
Ameditech Inc · initiated April 26, 2011
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.
Codes / lots: Lot Numbers: 110669 & 100093
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.
FDA-determined cause: Process control
Action taken
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 amd.complaint@alere.com or call 858-535-1968.
Details
- Recall number
- Z-2670-2011
- Initiated
- April 26, 2011
- Posted by FDA
- June 27, 2011
- Terminated
- August 11, 2011
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Quantity
- 6000 test cards (120 kits)
- Distribution
- Nationwide Distribution
- Recalling firm
- Ameditech Inc, San Diego, CA