Recall Z-3084-2017 ยท LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
Ameditech Inc
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
| Date | Jun 26, 2017 |
| Status | Terminated |
| Reason | 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 | Labeling Change Control |
| Action | 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 notifi |
| Quantity | 263Kits |
| Distribution | Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 Branan Medical Corp., Jul 30, 2002 |