Recall archive
196 recalls · page 4 of 9
Reported Mar 25, 2020
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2020
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 4, 2020
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product…
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 customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this…
FDA (openFDA device enforcement)
Reported Feb 26, 2020
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A…
FDA (openFDA device enforcement)
Reported Dec 4, 2019
Atellica CH 930 Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
FDA (openFDA device enforcement)
Reported Oct 30, 2019
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
FDA (openFDA device enforcement)
Reported Aug 28, 2019
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2019
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — Negative Bias with Lot EA9227.
FDA (openFDA device enforcement)
Reported Jul 10, 2019
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — A steady upward trend in blank (u) absorbance was observed
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 15, 2019
Atellica IM 1300 Analyzer, Material Number 11066001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — There were multiple issues identified in the system software which required an update.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2019
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — Software Issues.
FDA (openFDA device enforcement)
Reported Mar 27, 2019
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 6, 2019
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical…
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 an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 5, 2018
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative…
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 confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the…
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to…
FDA (openFDA device enforcement)
Reported Oct 31, 2018
APTIO INPUT/OUTPUT MODULE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2018
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 5, 2018
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 20, 2018
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due…
1 more product in this recall
FDA (openFDA device enforcement)
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