Recalls / —
—#141183
Product
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C 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
- 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196
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 #141183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.