Recall Z-3047-2020— Ameditech Inc

Name: FDA recall Z-3047-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-18

Class II · Terminated

Class II FDA medical device recall by Ameditech Inc, initiated 2020-08-18, terminated 2024-09-30. It names one FDA 510(k) clearance: K122633. Product: First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B. Reason: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling..

Recalling firm: Ameditech Inc
Classification: Class II
Status: Terminated
Initiated: 2020-08-18
Terminated: 2024-09-30
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122633 — TOXCUP DRUG SCREEN CUPBranan Medical Corp.·cleared 2013-02-07

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

First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

Reason for recall

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

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