BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor… — Class II medical device recall Z-1314-2019
Terminated recall by Becton Dickinson & Co., reported 2019-05-22, distributed nationwide. Background calibration has the potential to cause false positive or false negative test results. An incorrect
| Recall number | Z-1314-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2019-04-03 |
| Classified | 2019-05-10 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, HK, JP, TW |
| Quantity | 124 |
| Serial numbers | 1603209035660, 1604209189G80, 16083090396J0, 16083090446J0, 16083090476J0, 16083090766J0, 16083190426J0, 16083190656J0, 16083190756J0, 16102993166N0, 16102993246N0, 1612139044GR0, 1703259291H60, 1710169021HM0, 17121990337S0, 17122792607S0, 1801039026J00, 1801159017J10, 1801159029J10, 1801159030J10, 1801159036J10, 1801159039J10, 1801159047J10, 1801159055J10, 1801169001J10 and 99 more |
| Model numbers | 256055 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1314-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.