FDA recall Z-1314-2019

Product

BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055

Reason for recall

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

Distribution

Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan

Key facts

Status

Terminated

Initiation date

2019-04-03

Report date

2019-05-22

Termination date

2020-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2019