Device Recall Medplus ER Drug Screen Test 의 리콜

Recall

35656

Class 2

Z-1315-06

2005-05-31

2006-08-01

Terminated

United States

2012-07-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46564

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.

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.