United StatesBD EpiCenter Microbiology Data Management System (e.g., Computer System Epicenter F/G Cat. 441002; COMPUTER OPTIPLEX EPICENTER SPARE Cat. 441421; Generic NUC 2 Cat. 445398; Nuc 5i5 Os Image Bow 2.X Cat. 443971), BD BACTEC Blood Culture Systems (multiple models and catalog numbers), BD MAX System (Cat. 44191609, 441927), BD Phoenix M50 Instrument (Cat. 443624), and BD Veritor Connect Software (Cat. 444881) are included in the recall. The recall was initiated because product service credentials used by some BD technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access that may affect the confidentiality, integrity and/or availability of the products and associated data.
What's being recalled
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
Recalling firm: Becton Dickinson & Co., Sparks, MD, United States.
How to identify it
1. Catalog Number: 441002; UDI/DI: 00382904410025; Serial Numbers: MXL8503690, 5xlz833, HCT26Q3, FB3D7F3, MY816005EF, EPSN0443, EPSN0445, EPSN0496, EPSN0500, 4WMW9R2, EPSN0509, EPSN0480, MXL8501ST4, 274kdz0276, 4CDFTJ1, 2PGX5V1, EPSN0484, EPSN0485, EPSN0486, EPSN0492, EPSN0494, EPSN0497, EPSN0498, EPSN0499, EPSN0462, EPSN0463, 5W5S252, 553H5M1, 9JG1M51, 9HB2H41, 4113NM1, 80KTQ02, 30KXLM1, EPSN0450, EPSN0451, EPSN0453, EPSN0456, EPSN0458, 550PS81, EPSN0466, EPSN0467, 8D00GY1, EPSN0469, EPSN0470, EPSN0471, EPSN0472, EPSN0474, 5TGRCP1, 5DSNS81, 4173NM1, H94Y7S1, CQZL2V1, 7ZFCPH1, H3VV7R1, 9OF0030, 107326, 107875, 107558, SNYHN1, 44YP282, 6CPBY02, EPSN0476, 2Y71FQ1, BRJ4197MTK, 5FCQ491, SNCB4Y7S1, 8S6Q2V1, JHL1ZD1, DZFCPH1, MXL7411G1W, F5S30B1, 8HR4W1, EPIDB6768, 11XTJQ1, EPISAM1, 3CR33002FV, JR5002013067, EPSN0510, EPSN0511, FT3841EPI, MXL5371H1F, MXL7411G1D, MXL7411G1Q, MXL7411G1N, MXL7191DW4, MLX7191DWQ, MLX7191DWW, MXL6191BM8, 48D2NM1, UB3788EPI5, MXL209140T, X1693649, EPSN0514, EPSN0516, EPSN0517, EPSN0520, EPSN0522, EPSN0523, EPSN0530, MXL72820P9, EPSN0532, EPSN0533, EPSN0534, EPSN0535, EPSN0536, EPSN0541, EPSN0543, EPSN0545, SAA70907WL, EPSN0558, EPSN0559, MXL922203Y, EPSN0560, EPSN0561, MXL9221PDD, EPSN0563, MXL9221PD3, EPSN0564, MXL9221PFW, EPSN0566, EPSN0567, EPSN0568, JR5002017009, 8CG927017D, 6ZNP1R1, MXL7520PM2, Epitraum, Epicenter PC Server, EPSN0550, EPSN0555, 9DK0C42, 5JWPCP1, EPSN0570, EPSN0572, 27PHT13, EPSN0573, EPSN0574, 46H8DH2, EPSN0575, MXL74413VS, EPSN0577, HQRL842, EPSN0578, QAZ123WSX, EPSN0579, BCTGDH2, EPSN0580, MXL7411GHJ, MXL7411GF7, MXL7411GH2, MXL7411GDY, MXL744159T, MXL7411GJZ, MXL850369Z, MXL85036TY, MXL9123R03, 18303, MXL9123R1L, mxl74413v7, EPSN0586, MP1523UE, EPSN0587, MXL74411QH, EPSN0588, 9SDZLP2, EPSN0589, 3CQ7Z03, EPSN0591, MXL85035W4, EPSN0592, MP1F459S, EPSN0594, B6PHT13, EPSN0590, MXL82219X9, EPSN0597, 6PZG833, DCQ7Z03, 6NZG833, 9NZG833, F4V9DZ1S2, BCSPDH2, MY735009LU, H217CH2, MY735009MS, MY737009LE, G6YE5330006W, 6ZQM1R1…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)