BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues
BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves potential accuracy and reproducibility failures in laboratory diagnostic testing with no reported illnesses or injuries. The hazard meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' as test inaccuracy could lead to delayed diagnosis or inappropriate treatment.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Piperacillin/Tazobactam 100/10 micrograms laboratory testing discs (Catalog Numbers 231691 and 231692) due to potential reproducibility, accuracy, and quality control failures. These discs are used in clinical and research laboratories for antibiotic susceptibility testing of Haemophilus influenzae bacteria.
Approximately 2.3 million units have been distributed nationwide in the United States and internationally. Potential failures may result in delayed test results, inaccurate results, product discard, delayed patient diagnosis, inappropriate antibiotic selection, or extended antibiotic exposure during treatment.
Laboratories and healthcare facilities using affected lots should discontinue use and contact Becton Dickinson & Co. for replacement products or further guidance. Clinicians should review susceptibility test results generated from recalled discs and consider retesting if appropriate for patient care decisions.
The recalled product
- Product
- BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 2,363,168
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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