Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3047-2020 — First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

U.S. FDA — Device Enforcement · United States · 2020-08-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3047-2020
Date of alert
2020-08-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ameditech Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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