Applied Biotech Inc Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
Brand
Applied Biotech Inc
Lot Codes / Batch Numbers
Lot Numbers Affected: 85699 and 85671
Products Sold
Lot Numbers Affected: 85699 and 85671
Applied Biotech Inc is recalling Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026