—#141902

Product

iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

FDA product code: JXM — Enzyme Immunoassay, Benzodiazepine
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K052115, K113046, K113501
Affected lot / code info: 141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650

Why it was recalled

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.com.

Recalling firm

Firm: Ameditech Inc
Address: 9940 Mesa Rim Rd, San Diego, California 92121-2910

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-11-16
Terminated: 2016-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141902. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.