Z-1315-06

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

Name: Z-1315-06 Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box
Creator: Applied Biotech Inc
Published: 2005-05-31
License: https://open.fda.gov/license/

Applied Biotech Inc / initiated 2005-05-31 / Terminated

FDA source

Applied Biotech Inc began a recall of Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box on 2005-05-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1315-06
Status: Terminated
Initiated: 2005-05-31
Posted: 2006-08-01
Terminated: 2012-07-25
Recalling firm: Applied Biotech Inc
Product: Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
Product code: LCM Enzyme Immunoassay, Phencyclidine
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.
FDA root cause: Other
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.
Quantity in commerce: Lot #85699: 71 kits (1775 devices) & Lot #85671: 44 kits (1100 devices)
Distribution: Nationwide (distributors in KS and OR).
Product codes and lots: Lot Numbers Affected: 85699 and 85671

Product code LCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)