—#141925

Product

ProScreen 10 Panel Cup, Item No. PSCup-10M

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: 142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651 151706 152165 152167 152168 153102 153107 153251 153411 153412 153633

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 #141925. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.