Siemens Healthcare Diagnostics Recalls

Hazard: False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.

Hazard: False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.

Hazard: Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.

Hazard: PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Hazard: Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.

Hazard: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.

Hazard: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.

Hazard: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.

Hazard: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.

Hazard: Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias.

Hazard: Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.

Hazard: ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples.

Hazard: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Hazard: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Hazard: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Hazard: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Hazard: Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.

Hazard: Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

Hazard: When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.