Manufacturer
111 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
Siemens is recalling Atellica CH A1c test kits that may produce depressed results when used with RCRP on the same analyzer. This could delay diabetes diagnosis or result in inadequate treatment decisions.
Siemens is recalling Atellica CH Urine Albumin test kits due to measurement error producing falsely low results. Samples with urine albumin above 40.0 mg/dL may report 6.2-40.0 mg/dL, affecting 4,885 units worldwide.
Siemens IMMULITE 2000 allergen testing devices are being recalled due to a barcode orientation defect that prevents correct recognition of tube positions in the allergen holder wedge when used with Zebra barcode scanners.
Siemens 3gAllergy Specific IgE Kit units have barcode orientation issues preventing correct tube scanning. With IMMULITE/Zebra scanners, the system cannot recognize proper tube position, risking incorrect allergen test results.
Siemens Food Panel 3 allergen test kits have a barcode orientation defect that causes incorrect tube position recognition. When used with specific laboratory instruments, the scanning error may result in misidentified allergen test results.
Siemens IMMULITE 2000 PTH diagnostic assay kits may produce falsely low results at the lower end of the measurement range. The affected lots have been distributed worldwide.
Siemens Healthcare's Atellica CH urinary and cerebrospinal fluid protein test (11,811 units) may produce falsely depressed results in patient samples and quality control materials. Affected laboratories should verify test results and contact the manufacturer.
Siemens Healthcare has recalled 2,020 units of its ADVIA hematology calibrator due to incorrect platelet value assignments that could affect test accuracy. The calibrator is used in laboratories worldwide.
Siemens is recalling a diagnostic control product used with laboratory hematology systems. The control material has incorrect platelet value assignments.
Siemens is recalling ADVIA hematology analyzer control products due to incorrect platelet (PLT) value assignments. Approximately 3,266 units are affected, with lot numbers TP253035 and TP253045.
Siemens recalls a hematology quality control material due to incorrect platelet value assignments that could affect laboratory testing accuracy and result validation.
Siemens is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect calibrator, quality control, and patient test results. The recall affects 1,625 units distributed in the United States, Canada, and the Bahamas.
Siemens Healthcare Diagnostics is recalling certain lots of homocysteine calibrators that may provide inaccurate test results due to calibrator instability.
Siemens Atellica IM Homocysteine Calibrator lots have calibration instability causing inaccurate test results. Affected calibrators do not meet assay reference interval specifications due to increased positive bias.
Siemens is recalling the Atellica CH C Reactive Protein assay due to incorrect software flagging that may cause erroneous test results. All lot numbers are affected and the product was distributed nationwide and internationally.
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.
Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.
Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.
Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.
Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.
Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.