—#209481

Product

Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

FDA product code: CIG — Diazo Colorimetry, Bilirubin
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K061719
Affected lot / code info: Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA;

Why it was recalled

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.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.

Timeline

Recall initiated: 2024-07-30
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.