Recall Z-2099-2023 ยท JQP Calculator/Data Processing Module, For Clinical Use
Becton Dickinson & Co.
BD Synapsys Informatics Solution, Catalog Number 444150
| Date | Jul 6, 2023 (initiated Jun 8, 2023) |
| Status | Open, Classified |
| Reason | There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly. |
| Root cause | Software design |
| Action | An URGENT: Medical Device Product Correction notification letter dated 6/8/23 was sent to customers. Please Take the Following Actions: 1) Read and understand the contents of this letter and return the Customer Response form clearly indicating the applicable contact person at your facility to support the assessment and arrangement of remote service of the BD Synapsys" informatics software. 2) BD Synapsys" Informatics software can continue to be used. However, when running tests and evaluating cultures, confirm the Accession number matches the Breadcrumb Navigation Menu. If the Accession numbe |
| Quantity | 102 systems |
| Distribution | US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.