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U.S. Department of Health and Human Services

Class 2 Device Recall Medplus ER Drug Screen Test

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 Class 2 Device Recall Medplus ER Drug Screen Testsee related information
Date Initiated by FirmMay 31, 2005
Date PostedAugust 01, 2006
Recall Status1 Terminated 3 on July 25, 2012
Recall NumberZ-1315-06
Recall Event ID 35656
Product Classification drug screen test - Product Code LCM
ProductMedplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
Code Information Lot Numbers Affected: 85699 and 85671
Recalling Firm/
Manufacturer		 Applied Biotech Inc
10237 Flanders Ct
San Diego CA 92121-2901
For Additional Information ContactCarmen Bergelin
858-713-9640
Manufacturer 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 Determined
Cause 2		Other
ActionRecall 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 CommerceLot #85699: 71 kits (1775 devices) & Lot #85671: 44 kits (1100 devices)
DistributionNationwide (distributors in KS and OR).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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