Recall Z-1542-2018— Ameditech Inc

Name: FDA recall Z-1542-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-15

Class III · Terminated

Class III FDA medical device recall by Ameditech Inc, initiated 2017-12-15, terminated 2019-02-11. It names one FDA 510(k) clearance: K022355. Product: Alere iScreen Dx Urine Drug Screen Card. Reason: 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..

Recalling firm: Ameditech Inc
Classification: Class III
Status: Terminated
Initiated: 2017-12-15
Terminated: 2019-02-11
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K022355 — QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61Branan Medical Corp.·cleared 2002-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alere iScreen Dx Urine Drug Screen Card

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.