BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Reported: May 22, 2019 Initiated: April 3, 2019 #Z-1313-2019
Product Description
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
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
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 32 units
- Distribution
- Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066. Recalled by Becton Dickinson & Co.. Units affected: 32 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Moderate. Recall number: Z-1313-2019.
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