Recall archive
195 recalls · page 5 of 9
Reported Jun 6, 2018
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for…
FDA (openFDA device enforcement)
Reported May 16, 2018
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or…
43 more products in this recall
FDA (openFDA device enforcement)
Reported May 9, 2018
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA 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 — May produce erroneously low results from specific well sets.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is 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 — An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI…
FDA (openFDA device enforcement)
Reported Dec 6, 2017
Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L,…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2017
Dimension Troponin 1 (TNI) Flex reagent cartridge
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2017
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the…
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 Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored…
FDA (openFDA device enforcement)
Reported Apr 12, 2017
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST,…
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 — Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST)…
FDA (openFDA device enforcement)
Reported Apr 5, 2017
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details · Reason for recall — Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine…
FDA (openFDA device enforcement)
Reported Mar 29, 2017
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues…
FDA (openFDA device enforcement)
Reported Mar 1, 2017
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously…
FDA (openFDA device enforcement)
Reported Feb 22, 2017
CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2017
Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the…
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 AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2017
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details · Reason for recall — Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2,…
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 is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material…
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 the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2016
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
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 is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for…
FDA (openFDA device enforcement)
Reported Nov 30, 2016
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an 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 · Reason for recall — Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.
FDA (openFDA device enforcement)
Reported Nov 23, 2016
Dimension Vista IRON Flex reagent cartridges
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 — Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 2, 2016
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM)…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2016
ADVIA Centaur XPT Immunoassay System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2016
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or…
FDA (openFDA device enforcement)
Reported Sep 28, 2016
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks…
FDA (openFDA device enforcement)
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