CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
BD BBL Sensi Disc Chloramphenicol- 30 ug, used recalled
Becton Dickinson & is recalling BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro, 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-1026-2024
- 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 Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Questions about this recall
Is BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro recalled?
Yes. Becton Dickinson & recalled BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro on 8 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1026-2024.
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. 230733¿¿ UDI-DI 00382902307334 Lots 1020750 1116997 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 2277205 3003821 3129527 3263117 9336993 0080290 0178844 0258758; Catalog No. 231274¿ UDI-DI 30382902312742 Lots 2277205 3003821 3129527 3263117 0057245 0080290 1057453 1116997 1148461 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 9336993
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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