Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Becton DickinsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list BD Diagnostics with 4 510(k) clearances, 1 AI-enabled device and 1 device recall. The most recent is a device recall dated Dec 14, 2015: BD Viper LT software, version 3.00H.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 14, 2015 | BD Viper LT software, version 3.00HClass II · BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the in | Device recalls |
| Jul 5, 2012 | BD MAX MRSA ASSAY, BD MAX INSTRUMENTK120138 · NQX | 510(k) clearances |
| Dec 15, 2009 | BD GENEOHM MRSA ACP ASSAYK093346 · NQX | 510(k) clearances |
| Dec 19, 2008 | BD GENEOHM CDIFF ASSAYK081920 · LLH | 510(k) clearances |
| Dec 20, 2007 | BD GENEOHM STAPHSR ASSAYK071026 · NQX | 510(k) clearances |
| Sep 29, 1995 | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEMP950009 · Pathology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
