MONOFLUO Pneumocystis jirovecii kit/ Bio-Rad Laboratories, Inc./ distribution error involving non-CE marked batches of MONOFLUO Pneumocystis jirovecii kits shipped to the EU, despite compliance with IVDD standards.
Trilogy EV300 Ventilator/ Philips Respironics/ aerosol deposits from in-line nebulizers in Trilogy Evo devices potentially impairing flow sensors
Laparoscopic Power Morcellators (LPM)/ All/risk of Laparoscopic Power Morcellators (LPM) dispersing cancerous cells during hysterectomy or myomectomy
MINICAP EXTEND LIFE PD TRANSFER SET/ Baxter Healthcare/ potential separation of the female connector from the main body in MiniCap Extended Life PD transfer sets
HeartStart Intrepid Monitor/Defibrillator/ Philips Healthcare/ intermittent ECG waveform display in HeartStart Intrepid Monitor/Defibrillators when using 5-Lead or 10-Lead ECG cables with the fourth limb lead placed on the patient.
lntelliVue Patient Monitor/ Philips/ potential loss of electrical grounding in IntelliVue Patient Monitors MX400–MX550
N Latex RF Kit/ Siemens Healthcare Diagnostics Inc./ Presence of white precipitates in specific vials of the N RF Reagent, potentially leading to flagged calibration, quality control errors
Atellica IM Rubella IgG/ Siemens Healthcare Diagnostics Inc./ potential for invalid calibrations with the Atellica IM and ADVIA Centaur Systems Rubella IgG assay
Q-Stress Software Version V6.1.0 -V6.4.1/ Welch Allyn Inc./ potential for duplicate Unique Identifiers (UIDs) in Q-Stress, which may lead to mismatched medical records and inaccurate ECG data
Giraffe OmniBed & Giraffe OmniBed Carestation/ improperly torqued screws securing heater doors in certain Giraffe OmniBed and Carestation devices, which may lead to loose doors
K-Systems™ G73 Block Warmer & K-Systems™ R65 Trolley/ CooperSurgical / Potential deviation in temperature regulation in K-Systems devices, where temperatures may exceed the set point
PTH STAT Elecsys cobas e 100 V2 & PTH Elecsys cobas e 100 V2/ Roche Diagnostics/ Incorrect calibration frequency setting in the electronic application files for Elecsys® PTH V2 and PTH STAT V2 assays on cobas® e 60x and cobas® e 411analyzers.
Lactate Gen.2 100 & 225 tests/ Roche Diagnostics/ Updated interference limits for NAcetylcysteinein Lactate Gen.2 assays on cobas® c systems
Vaporizer Sevoflurane, Quik-Fil/ Getinge/ chemical degradation of low-water-content Sevoflurane in specific vaporizers, leading to the potential formation of hydrogen fluoride,
Anti-TPO Elecsys E2G 300/ Roche Diagnostics/ falsely elevated recovery results with Elecsys® anti-TPO assays on cobas® e 801 and e 402 analytical units
D-Dimer Gen.2 Calibration & Control set/ Roche Diagnostics/ incorrect expiry date encoded in e-barcodes for certain lots of D-Dimer Gen.2 Calibrator and Control Sets
IgE G2 Elecsys E2G 100/ Roche Diagnostics/ discrepancy in calibration frequency for IgE II E2G assay on cobas® e 801 and e 402 modules, caused by incorrect application file settings
BD Alaris™ Pump & BD Alaris™ SYR/ BD / identified defects in the Female/Left IUI connectors of BD Alaris™ System devices, where bent or misaligned pins could disrupt connectivity
Atellica IM Total Thyroxine/ Siemens Healthcare Diagnostics Inc./ Reduction in the calibration interval for Atellica IM Total Thyroxine (T4) assays from 21 days to 4 days
Atellica CH Revised C‑Reactive Protein (RCRP)/ Siemens Healthcare Diagnostics Inc./ occurrence of 'No Calculation' flags in the Atellica CH RCRP assay on the Atellica CH Analyzer for C-Reactive Protein (CRP) concentrations below 0.05 mg/dL (<0.5 mg/L).
Iron Gen.2 (IRON 2)/ Roche Diagnostics/ throughput-dependent signal drifts in Iron Gen.2 (IRON2) assays on cobas® c 311, c 501/502, and COBAS INTEGRA® 400 plus analyzers, causing up to +4.7 μmol/L bias, especially in high-throughput settings.
BD PCR Cartridge/ Becton Dickinson /Signal drift in specific lots of BD PCR Cartridges, leading to false-positive results for influenza A in BD MAX™ RVP assays and an increased frequency of unresolved results in other molecular assays
Alanine Aminotransferase acc. to IFCC II (ALTP2) / Roche Diagnostics/ Implementation of a standardization correction factor of 1.075 for Alanine Aminotransferase acc. to IFCC II (ALTP2) in calibrators and controls, addressing minor systematic recovery deviations of patient samples.
epoc® Blood Analysis System/ Siemens Healthcare Diagnostics/ Connectivity issue in the epoc® NXS Host system
BD EpiCenter™ Microbiology Data Management System & BD Phoenix™ M50 Automated Microbiology System & BD BACTEC™ Blood Culture System & BD Phoenix™ M50 & BACTEC FX40 & BACTEC FX & BD MAX™ System/ Becton Dickinson / Potential cybersecurity vulnerabilities in BD diagnostic systems
Elecsys Folate III & Elecsys Vitamin B12 II / Roche Diagnostics/ limited onboard stability for Elecsys® Folate III and Vitamin B12 II assays on cobas® e 402 analyzers, leading to calibration failures and out-of-range QC recovery
Ultraview Universal DAB Detection Kit/ Roche Diagnostics/ inclusion of an incorrect PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONO dispenser in the ultraView Universal DAB Detection Kit
Vista 120/ Drager/ the device can freeze under certain conditions without triggering an alarm or automatic restart
Vitros XT 7600 integrated system/ QUIDEL ORTHO /Expired Signal Reagent (SR) packs may not trigger the Reagent Expired (RE) result code
Atellica CH Revised C‑Reactive Protein (RCRP)/ Siemens Healthcare Diagnostics Inc./ occurrence of 'No Calculation' flags in the Atellica CH RCRP assay on the Atellica® CH Analyzer for CRP concentrations below 0.05 mg/dL (<0.5 mg/L),
PHOS. Gen.2, 250Tests,cobas c, Integra/ Roche Diagnostics/ Calibration failures in PHOS2 and PHOU2 assays on COBAS INTEGRA® 400 plus analyzers, caused by modified photometers shifting raw absorption values beyond predefined R0 check limits.
BIOFIRE®FILMARRAY®Pneumonia Panel/ Biomerieux/ Risk of false positive Coronavirus results in BIOFIRE® FILMARRAY® Pneumonia (PN) and PNplus Panels
HeartWare TM Ventricular Assist Device (HVAD ™) System/ Medtronic/ Increased number of reports of HVAD™ controllers being inadvertently left in manual start mode during controller exchanges.
Access 2 Immunoassay Analyzer/ Beckman Coulter /Improper alignment of the sample motor to the sample wheel in certain Access 2 Immunoassay Analyzers
PHOS. Gen.2, 250Tests,cobas c, Integra/ Roche Diagnostics/ Modified photometers in COBAS INTEGRA® 400 plus analyzers, causing shifts in raw absorption values for PHOS2 and PHOU2 assays
Flow-i/ Getinge/ cybersecurity vulnerability in Flow Family Anesthesia systems (versions 4.7 and below) allowing potential remote code execution or Denial of Service (DoS) attacks during Ethernet-connected data transfers
Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp)/ Baxter/ potential exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) and polychlorinated biphenyls (PCBs) in MiniCap Extended Life PD Transfer Sets with peroxide-cured silicone tubing
Access hsTnI Reagent Kit/ Beckman Coulter/ risk of cardiac troponin I (cTnI) carryover when high cTnI samples (>55,000 pg/mL) are tested using an Access assay other than Access hsTnI.
PROGRAMMER LATITUDE US/ Boston Scientific/ high battery impedance in a subset of ACCOLADE™, PROPONENT™, ESSENTIO™, ALTRUA™ 2, VISIONIST™, and VALITUDE™ pacemakers and CRT-Ps, which may trigger Safety Mode during telemetry or high-power operations
NIM Vital™ Nerve Monitoring System Stimulus Artifact/ Medtronic/ increased stimulus artifact in the NIM Vital™ Nerve Monitoring System which may result in false event detections during surgical procedures
Non-Automated Blood Pressure Gauges/ BAXTER/ The potential for Welch Allyn non-automated blood pressure gauges to fail leak and accuracy specifications after exposure to high-temperature storage
HLS Set Advanced 7.0 with BIOLINE Coating/ Getinge/ risk of compromised sterility in HLS Set Advanced 5.0 and 7.0 caused by internal packaging components puncturing the Tyvek cover
Atlan A300 & Atlan A350/ Drager/ potential failure of automatic mechanical ventilation in Dräger Atlan anaesthesia workstations, caused by an error in the motor electronics resulting from a temporary deviation in the assembly process.
Primus & Primus IE & Zeus IE/ Drager/ potential risk of incorrect connection of oxygen (O₂) reserve gas cylinders to Dräger anaesthesia workstations.
Centricity Universal Viewer/ GE HEALTHCARE/ Cybersecurity vulnerability in GE HealthCare’s Centricity Universal Viewer, where service login credentials may be exposed
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