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Terminated

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

FDA Recall Z-1315-06 · Posted 2006-08-01

Recalling FirmApplied Biotech Inc
Recall StatusTerminated
Product CodeLCM
Date Initiated2005-05-31
Date Terminated2012-07-25
Product QuantityLot #85699: 71 kits (1775 devices) & Lot #85671: 44 kits (1100 devices)

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.

Firm Action

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

Distribution Pattern

Nationwide (distributors in KS and OR).

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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