BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
Reported: February 14, 2024 Initiated: January 8, 2024 #Z-1035-2024
Product Description
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 2,363,168 total units
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿. Recalled by Becton Dickinson & Co.. Units affected: 2,363,168 total units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-1035-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11