Recall Z-1014-2024— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.. Reason: 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-08
- Firm location
- Sparks, MD, United States
Product description
BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.