Recalls / —
—#162621
Product
Alere iScreen Dx Urine Drug Screen Card
- FDA product code
- LFH — U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Device class
- Class 2
- Medical specialty
- Clinical Toxicology
- 510(k) numbers
- K022355
- Affected lot / code info
- Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
Why it was recalled
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Root cause (FDA determination)
Labeling Change Control
Action the firm took
Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.
Recalling firm
- Firm
- Ameditech Inc
- Address
- 9940 Mesa Rim Rd, San Diego, California 92121-2910
Distribution
- Distribution pattern
- Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Timeline
- Recall initiated
- 2017-12-15
- Terminated
- 2019-02-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.