Siemens Healthcare Diagnostics Recalls

Hazard: The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.

Hazard: May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

Hazard: The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

Hazard: Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv

Hazard: Complaints of failed calibration.

Hazard: Complaints of failed calibration.

Hazard: There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

Hazard: RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)

Hazard: RAPIDComm¿ 5.0 Screen Layout will display incorrect test names

Hazard: The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

Hazard: The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.

Hazard: Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.

Hazard: ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).

Hazard: Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

Hazard: Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

Hazard: Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.

Hazard: Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.

Hazard: A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Hazard: A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista¿ CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C

Hazard: Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223

Hazard: Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.

Hazard: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

Hazard: Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.