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

BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055 — recall Z-1314-2019

U.S. FDA — Device Enforcement · United States · 2019-04-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1314-2019
Date of alert
2019-04-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton Dickinson & Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1603209035660
Reported risk: Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.