FDA (Devices) recall action 93789

Becton Dickinson & Co. recalled 30 products on 2024-02-14

The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.

Products: 30
Announced: 2024-02-14
Critical: 0
Units: 70,895,040

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 30

HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Ampicillin testing discs recalled for accuracy failures
Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Levofloxacin Testing Discs Recalled for Accuracy Failures
Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Ertapenem Susceptibility Test Discs Recalled for Accuracy Failures
BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, delayed diagnosis, or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.
Product
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.
Product
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD Sensi Disc Cefpodoxime Antibiotic Testing Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures
BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.
Product
BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures
BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.
Product
BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures
BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.
Product
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures
BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.
Product
BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns
BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.
Product
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Moxifloxacin Test Discs Recalled for Susceptibility Testing Inaccuracy
BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
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.
Product
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
Antibiotic susceptibility test discs recalled for accuracy and quality failures
Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled
BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.
Product
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
Lab testing discs recalled for potential antibiotic susceptibility testing failures
Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
Antibiotic Susceptibility Test Discs Recalled for Accuracy and QC Failures
Becton Dickinson is recalling BD BBL Sensi Disc Minocycline test discs due to potential accuracy and quality control failures that may cause delayed test results, missed diagnoses, or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
Medical Device Recall: BD BBL Cefaclor Antibiotic Susceptibility Test Disc
Becton Dickinson is recalling BD BBL Sensi Disc Cefaclor antibiotic susceptibility test discs due to possible accuracy and quality control failures. Affected discs may produce inaccurate results, risking delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD Sensi Disc Cefepime antibiotic susceptibility testing accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.
Product
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis
Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.
Product
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD antibiotic susceptibility test discs recalled for possible accuracy failures
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
Category
Distribution
0 states
HighFDA (Devices)··2024-02-14
BD Antibiotic Testing Discs Recalled for Accuracy Failures
Becton Dickinson recalled BD BBL Sensi Disc Augmentin testing discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Failures may lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
Category
Distribution
0 states