BD Synapsys Informatics Solution recall
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Why was BD Synapsys Informatics Solution 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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,
- Product
- BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 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.
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)