Z-0591-2025Class II

BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

Name: Z-0591-2025 BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Creator: Becton Dickinson & Co.
Published: 2024-10-31
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-10-31 / Open, Classified / root cause: software

FDA source

Becton Dickinson & Co. began a recall of BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150 on 2024-10-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0591-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-31
Posted: 2024-12-03
Recalling firm: Becton Dickinson & Co
Product: BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On October 31, 2024 URGENT" MEDICAL DEVICE PRODUCT CORRECTION letters were sent to consignees. IT, Safety and Security Actions to be Taken: BD encourages customers to follow best practices for maintaining strong security measures to protect hospital networks and medical devices including: "Ensure access to potentially vulnerable devices is limited to authorized personnel "Inform authorized users of issue, and ensure all relevant passwords are tightly controlled "Monitor and log network traffic attempting to reach medical device managementenvironments for suspicious activity "Where possible, isolate affected devices in a secure VLAN or behind firewalls with restrictedaccess that only permits communication with trusted hosts in other networks when needed "Impacted devices do not require use of RDP ports and these should be disabled or blockedif enabled "Ensure permissions on file shares are appropriately established and enforced, and monitorand log access for evidence of suspicious activity "Disconnect devices from the network if connectivity is not necessary Next Steps to be Taken by Customer: 1.Ensure the contents of this notification are read and understood. 2.Share and post this customer letter within your facility network including IT and safety andsecurity department. Forward to any customers to whom you may have distributed theproduct(s) to ensure awareness. 3.Complete the attached Customer Response Form and return it to the BD contact noted on theForm so that BD may acknowledge your receipt of this notification per FDA requirements. 4.Report any adverse health consequences experienced with the use of these products to BD.Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 If you require further assistance, please contact: Technical Service +1 888 451 5514 Technical Questi
Quantity in commerce: 56 units (OUS only)
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.
Product codes and lots: Catalog No: 444150; UDI-DI: 00382904441500; Serial Numbers: JRPN215003AB, BTDN93800189, JRPN215003VS, BTDN938000WP, BTDN938000XZ, BTDN93600B4R, BTDN0160058Z, BTDN939007WP, BTDN938000Z3, BTDN940003G5, BTDN932008FF, BTDN94000424, BTDN940003AV, BTDN938000WY, JRPN215003UA, JRPN215003M8, BTDN01800017, JRPN215003V7, BTDN934008WP, JRPN215003M4, BTDN939007Z9, JRPN2150038H, BTDN9380016F, BTDN938000WU, BTDN938001FL, JRPN215004L1, BTDN93600B0K, JRPN215003E8, BTDN934008S2, BTDN93600B3E, JRPN215004R7, JRPN215003CL, BTDN93600B5G, BTDN9200040Q, JRPN215004J9, JRPN21500418, BTDN934008UD, BTDN920003X8, JRPN215003JT, BTDN0180005Q, JRPN215003CZ, BTDN018000DT, JRPN215003CR, BTDN934008T2, JRPN215003M1, JRPN215003HR, JRPN215003TN, BTDN934008CE, BTDN932009P7, JRPN215003JG, JRPN215003X3, BTDN926003PU, BTDN928007ZA, BTDN926003UW, BTDN933008XS, BTDN9380014T.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0584-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0585-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0586-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0587-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0588-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0589-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0590-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0591-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0592-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0593-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0594-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0595-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03
Z-0596-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-03

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)