Recall Z-1315-06 ยท LCM Enzyme Immunoassay, Phencyclidine
Applied Biotech Inc
Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
| Date | Aug 1, 2006 (initiated May 31, 2005) |
| Status | Terminated |
| 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). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.