Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.

FDA device recall Z-1315-06 · posted 2006-08-01 · Terminated

Recall details

Recalling firm

Applied Biotech Inc

Reason for recall

The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in vitro test for rapid detection of various drugs such as Amphetamines, Barbiturates, Phencyclidine, Cocaine, Methamphetamine, Tricyclic Antidepressants, Morphine, Tetrahydrocannabinol, & Benzodiazepines in human urine.

Action taken

Recall notifications that describe the problem, dated May 31,2005, were sent via fax. Customers were instructed to block all stock of affected lots in their warehouse, contact their primary consignees and advise them to discontinue use immediately and dispose any unused materials. A faxback form was used to communicate to the recalling firm the quantity blocked and disposed of. Arrangements were made for providing replacement product.

Root cause

Other

Status

Terminated

Product code

LCM

Quantity affected

Lot #85699: 71 kits (1775 devices) & Lot #85671: 44 kits (1100 devices)

Distribution

Nationwide (distributors in KS and OR).

Date initiated

2005-05-31

Date posted

2006-08-01

Date terminated

2012-07-25

Location

San Diego, CA