NA R30957301Recalls & reported problems
Remel Europe Limited · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 25, 2026Open, Classified
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Z-1923-2026 · Root cause: Under Investigation by firm · FDA record ↗
Other Antisera, All Groups, Salmonella Spp. devices
- BD Difco™ Salmonella O Antiserum Factor 7 228161Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.4 reports
- BD Difco™ Salmonella O Antiserum Group E Factors 1, 3, 10, 15, 19, 34 228191Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.2 reports
- BD Difco™ Salmonella H Antiserum Single Factor 2 224741Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.2 reports
- BD Difco™ Salmonella H Antiserum Single Factor 5 224751Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.2 reports
- BD Difco™ Salmonella O Antiserum Group A Factors 1, 2, 12 229471Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.1 report
- BD Difco™ Salmonella H Antiserum Single Factor t 225511Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.1 report
- BD Difco™ Salmonella O Antiserum Group C1 Factors 6, 7 229491Becton, Dickinson And Company · ANTISERA, ALL GROUPS, SALMONELLA SPP.1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.