CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
BD BBL Sensi Disc Ertapenem- 10 ug, used recalled by Becton Dickinson &
Becton Dickinson is recalling BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility, distributed nationwide in the US. The recall was initiated on 8 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1030-2024
- FDA event ID
- 93789
- Recalling firm
- Becton Dickinson, Sparks, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2024
- FDA classified
- 8 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Jan 2024 | Recall initiated by company | |
| 8 Feb 2024 | Classified by FDA | +31 days |
| 14 Feb 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Questions about this recall
Why was it recalled?
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Which lots are affected?
Catalog No. 232174 UDI-DI 00382902321743 Lots 1301766 1341479 2119610 2147329 2242618 2276113 2333166 3152004 3181140; Catalog No. 232175¿ UDI-DI 30382902321751 Lots 1301766 2276113 2333166 2333175 3152004 3181140 1341479 2119610 2119612 2147329 2242618
Where was it sold?
Domestic distribution nationwide. International distribution worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
29 other products · FDA event 93789This product is part of a recall event; the main page for the event is BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug recalled.
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