Becton Dickinson Recalls BD GeneOhm Cdiff Assay Due to Tube Leakage
Becton Dickinson & Co. is recalling 32 kits of the BD GeneOhm Cdiff Assay because reaction tubes may leak. The product is distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 32 kits of the BD GeneOhm Cdiff Assay, Catalog # 441401. The recall is due to leakage in Cepheid SmartCycler reaction tubes. The affected lot is 08T11250 with an expiration date of 2012-07-06.
The BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test used to detect the C. difficile toxin gene in human stool specimens. It is intended to aid in the diagnosis of Clostridium difficile-associated disease (CDAD). The product was distributed nationwide to states including California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin, and West Virginia.
Healthcare facilities and consumers should stop using the affected product and contact Becton Dickinson & Co. for further instructions or a replacement.
The recalled product
- Product
- BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C.…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/ Exp. 08T11250 2012-07-06
Distribution
Part of a larger recall action
This product is one of 5 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
- HighAutomated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBlood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighBD GeneOhm Cdiff Assay Recalled Due to Incorrect Reagent Packing
FDA (Devices) · 2014-01-29
- ModerateBecton Dickinson Recalls Gonorrhea Test Kits Due to False Positives
FDA (Devices) · 2013-05-15
- ModerateBecton Dickinson Recalls BD MAX PCR Cartridges Due to Sealing Defects
FDA (Devices) · 2013-04-03
- ModerateBecton Dickinson Recalls BD MAX Reagent Extraction Tubes Due to Seal Defect
FDA (Devices) · 2019-08-28
- ModerateBD MAX Cdiff EU Reagent Kits Recalled for Improperly Sealed Foil Bags
FDA (Devices) · 2019-08-28
- HighBD FACSLyric Flow Cytometer Recalled for Potential False High Counts
FDA (Devices) · 2019-10-16