Class 2 Device Recall Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge

• Date Initiated by Firm: July 30, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3065-2024
• Recall Event ID: 95116
• 510(K)Number: K061719
• Product Classification: Diazo colorimetry, bilirubin - Product Code CIG
• Product: Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146
• Code Information: Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr; Newark DE 19702-2466
• For Additional Information Contact: Beth Coolbaugh; 800-441-9250
• Manufacturer Reason for Recall: During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.
• FDA Determined Cause: Software Manufacturing/Software Deployment
• Action: On July 30, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Impact to Results: 1. Erroneously depressed or elevated total bilirubin patient results may have occurred, even if QC was within range. 2. A negative bias of >-98% (erroneous result <0.1 mg/dL [2 mol/L] at a true concentration of 4.0 mg/dL [69 mol/L]) and a positive bias of up to 3,950% (erroneous result 16.2 mg/dL [277 mol/L] at a true concentration of 0.4 mg/dL [7 mol/L]) was observed. Results of this test should always be interpreted in conjunction with the patient s medical history, clinical presentation and other findings. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Complete and return the Field Correction Effectiveness Check form attached within 30 days and indicate product replacement needs if retesting of patients is performed. 3. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution: The cause of the filling issue has been determined and resolved by Siemens Healthineers. Mitigation that will prevent this issue from occurring in the future has been put in place. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
• Quantity in Commerce: 5,371 units (4,394 US, 977 OUS)
• Distribution: Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CIG