Recall Z-3065-2024 ยท CIG Diazo Colorimetry, Bilirubin
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
| Date | Sep 6, 2024 (initiated Jul 30, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061719 | DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 Dade Behring, Inc., Aug 25, 2006 |