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Dimension Vista Total Bilirubin (TBIL) Flex Reagent… recallZ-3065-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 30, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software Manufacturing/Software Deployment

What the company is doing

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.

Recall details

Recall number
Z-3065-2024
Status
Open, Classified
Initiated by the company
Jul 30, 2024
Posted by the FDA
Sep 6, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
5,371 units (4,394 US, 977 OUS)
Product code
CIG
FDA submissions
K061719
Distribution
Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.

Product description

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

Code information (models, lots, serial numbers)

Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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