CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
BD BBL Sensi Disc Tetracycline 30 ug,used recalled by Becton Dickinson &
Becton Dickinson & is recalling BD BBL Sensi Disc Tetracycline 30 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-1040-2024
- 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 Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Questions about this recall
Is BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility recalled?
Yes. Becton Dickinson & recalled BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility on 8 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1040-2024.
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. 230998 UDI-DI 00382902309987 Lots 1242880 1277918 1301570 2025088 2056233 2118569 2276681 3094187 3212760 3263267 9009914 9046895 0065366 0178210; Catalog No. 231344¿ UDI-DI 30382902313442 Lots 3010027 3062263 3094187 3158029 3212760 3263267 3275644 0065366 0085202 0230453 0274792 0335906 1095603 1148539 1180271 1242880 1277918 1301570 2025088 2056233 2089874 2118569 2276681 8355562 9009914 9046895 9130797 9239639 9263061
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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