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

Recall Z-0417-2015 — MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

U.S. FDA — Device Enforcement · United States · 2014-10-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0417-2015
Date of alert
2014-10-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Diagnostic Hybrids Inc
Product category
device
Product type
Devices
Reported risk: Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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