Recall archive
197 recalls · page 6 of 9
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)
Reported Aug 3, 2016
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in…
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 has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2016
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — Eight (8) issues were identified which may affect the results generated by the system software version.
FDA (openFDA device enforcement)
Reported May 25, 2016
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in 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 confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU)…
FDA (openFDA device enforcement)
Reported May 18, 2016
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2016
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a…
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 — Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or…
FDA (openFDA device enforcement)
Reported Mar 9, 2016
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot…
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 an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 10, 2016
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range…
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. ---…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000,…
FDA (openFDA device enforcement)
Reported Dec 2, 2015
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 4, 2015
ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An 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 — ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after…
FDA (openFDA device enforcement)
Reported Sep 16, 2015
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical…
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 has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for…
FDA (openFDA device enforcement)
Reported Sep 2, 2015
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various…
FDA (openFDA device enforcement)
Reported Aug 26, 2015
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain…
FDA (openFDA device enforcement)
Reported Jul 15, 2015
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in…
FDA (openFDA device enforcement)
Reported Jul 8, 2015
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2015
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24…
FDA (openFDA device enforcement)
Reported Jun 10, 2015
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2015
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is…
FDA (openFDA device enforcement)
Reported May 20, 2015
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The…
FDA (openFDA device enforcement)
Reported Apr 29, 2015
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA…
FDA (openFDA device enforcement)
Reported Apr 15, 2015
QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1%…
1 more product in this recall
FDA (openFDA device enforcement)
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