Reported Dec 11, 2024 · Ongoing
BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
- BD
- BACTEC FX40 Instrument Version or Model442296
- Catalog Number442296
- Lot codes and dates
- Catalog No442296
- UDI-DI00382904422967
- Serial Numbers
4,067 of 4,067 codes
FF7385FF7425FF2727FF1261FF2717FF1262FF7254FF7365FF7419FF7374FF6762FF2759FF2756FF7380FF9548FF9544FF7367FF2745FF7615FF2789FF1371FF7208FF7481FF7294FF7225FF7258FF2760FF9091FF7875FF6519FF6835FF2838FF9860FF7293FF9668FF9469FF4440FF9484FF4506FF9796FF9602FF2835FF7238FF2836FF6984FF9637FF9689FF9690FF9700FF9706FF9743FFA832FFA846FF9264FF9734FF6896FF9735FF9737FF9800FF2844
- Amount recalled
- 8,085 units (838 US, 7,247 OUS)
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
This product could cause temporary or reversible health problems — stop using it.
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