FDA Medical Device Recalls (openFDA)
Applied Biotech Inc: Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
- Recall number
- Z-1315-06
- Recalling firm
- Applied Biotech Inc
- Product
- Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
- Status
- Terminated
- Initiated
- 2005-05-31
- Posted
- 2006-08-01
- Terminated
- 2012-07-25
- Reason
- 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.
- 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
- Lot #85699: 71 kits (1775 devices) & Lot #85671: 44 kits (1100 devices)
- Distribution
- Nationwide (distributors in KS and OR).
- Lot, serial or model codes
- Lot Numbers Affected: 85699 and 85671
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LCM
- Firm FEI
- 1000125390
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28