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

FDA device recall Z-2670-2011 · posted 2011-06-27 · Terminated

Recall details

Recalling firm

Ameditech Inc

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.

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.

Root cause

Process control

Status

Terminated

Product code

DKZ

Quantity affected

6000 test cards (120 kits)

Distribution

Nationwide Distribution

Date initiated

2011-04-26

Date posted

2011-06-27

Date terminated

2011-08-11

Location

San Diego, CA

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