—#157665

Product

Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine

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: P/N IS10-DX; Lot No. U0731

Why it was recalled

The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX

Timeline

Recall initiated: 2017-06-26
Terminated: 2019-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157665. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.