BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Ca...
FDA Device Recall #Z-1314-2019 — Class II — April 3, 2019
Recall Summary
| Recall Number | Z-1314-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 3, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Co. |
| Location | Sparks, MD |
| Product Type | Devices |
| Quantity | 124 |
Product Description
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 Pattern
Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
Lot / Code Information
Serial Numbers: Serial Number 1801179131J10 1801179119J10 1801179139J10 1801179117J10 1801179110J10 1801179115J10 1801159055J10 1801179120J10 1801159036J10 1801179109J10 1801179095J10 1801179128J10 1801189173J10 1801189181J10 1801189108J10 1801189146J10 1801189140J10 1801189126J10 1801189184J10 1801189159J10 1801179092J10 1801179137J10 1612139044GR0 1801179121J10 1801179124J10 1801179148J10 16102993246N0 1801159030J10 1801189102J10 1801189132J10 1801189166J10 1801169045J10 1801169012J10 1801169057J10 1801169049J10 1801169003J10 1801179155J10 1801179142J10 1710169021HM0 16102993166N0 1801169001J10 1801179096J10 1801179111J10 1801189176J10 1801189177J10 1801189180J10 1801169005J10 1801179094J10 1801179175J10 1801179113J10 1801179125J10 1801189104J10 1801189073J10 1801189082J10 1801169018J10 1801179157J10 1801179162J10 1801179156J10 1801189158J10 1801179105J10 1801179133J10 17122792607S0 1801169048J10 1801189183J10 1801189170J10 1801169051J10 1801169058J10 1801189127J10 1801179141J10 1801189178J10 1801189152J10 1801179144J10 1801179145J10 1603209035660 17121990337S0 1801179149J10 1801179165J10 1801159017J10 1801189106J10 1801179153J10 1801179154J10 1801179112J10 1801179101J10 1801189107J10 1801189168J10 16083090396J0 16083090446J0 16083090476J0 16083090766J0 16083190426J0 16083190656J0 1801189169J10 1801039026J00 1801189135J10 16083190756J0 1801169060J10 1801169056J10 1801169004J10 1801179130J10 1801179098J10 1801179114J10 1801179136J10 1801179134J10 1801179122J10 1703259291H60 1801189116J10 1604209189G80 1801159029J10 1801189063J10 1801189072J10 1801169019J10 1801179147J10 1801189182J10 1801189174J10 1801169050J10 1801169052J10 1801169006J10 1801189151J10 1801189061J10 1801189090J10 1801189167J10 1801189160J10 1801159039J10 1801159047J10
Other Recalls from Becton Dickinson & Co.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0484-2026 | Class II | BD Kiestra" Isolate Suspension Cuvette Array; ... | Oct 23, 2025 |
| Z-0235-2026 | Class II | BD EpiCenter Microbiology Data Management Syste... | Sep 23, 2025 |
| Z-0236-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
| Z-0240-2026 | Class II | BD Veritor Connect Software, labeled as the fol... | Sep 23, 2025 |
| Z-0237-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.