—#141178

Product

CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

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: 142320 143666 143753 144217 144414 144439 144454 144510 144952

Why it was recalled

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to amt.fieldaction@alere.com. For questions regarding this recall call 858-535-1968.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia.

Timeline

Recall initiated: 2015-10-20
Terminated: 2016-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141178. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.