Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Roche Diagnostics Operations
Class I - Dangerous
Inaccurately Low Sample Results
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Stryker Instruments Div. of Stryker
Class I - Dangerous
Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
WOM World of Medicine AG
Class I - Dangerous
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
The touchpad may not work properly after cleaning.
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Stryker Instruments Div. of Stryker
Class I - Dangerous
Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Helena Laboratories
Class I - Dangerous
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Randox Laboratories
Class I - Dangerous
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure
Class I - Dangerous
Instrument stopped working due to a software lockup, and no patient results are produced.
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
Philips North America
Class I - Dangerous
The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Stryker Communications
Class I - Dangerous
The mounts on the monitor may have an insufficient weld.