Recall archive
195 recalls · page 7 of 9
Reported Jan 21, 2015
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same…
FDA (openFDA device enforcement)
Reported Jan 14, 2015
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for…
FDA (openFDA device enforcement)
Reported Dec 31, 2014
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details
FDA (openFDA device enforcement)
Reported Dec 3, 2014
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for…
FDA (openFDA device enforcement)
Reported Nov 19, 2014
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2014
Dimension Vista¿ HbA1c
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2014
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability…
FDA (openFDA device enforcement)
Reported Oct 8, 2014
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following…
FDA (openFDA device enforcement)
Reported Sep 24, 2014
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may…
FDA (openFDA device enforcement)
Reported Sep 10, 2014
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been…
FDA (openFDA device enforcement)
Reported Sep 3, 2014
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact…
FDA (openFDA device enforcement)
Reported Aug 27, 2014
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on…
FDA (openFDA device enforcement)
Reported Aug 6, 2014
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by…
FDA (openFDA device enforcement)
Reported Jul 9, 2014
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2014
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2014
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — 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.
FDA (openFDA device enforcement)
Reported May 28, 2014
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample…
FDA (openFDA device enforcement)
Reported Mar 5, 2014
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the…
FDA (openFDA device enforcement)
Reported Feb 19, 2014
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control…
FDA (openFDA device enforcement)
Reported Feb 5, 2014
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a…
FDA (openFDA device enforcement)
Reported Jan 29, 2014
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2014
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and…
FDA (openFDA device enforcement)
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