Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
Class I - Dangerous
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Mindray DS USA, Inc.
Class I - Dangerous
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
Class I - Dangerous
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Class I - Dangerous
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
3M Company - Health Care Business
Class I - Dangerous
It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
Class I - Dangerous
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Access Thyroglobulin, A34085G, Catalog No. 33860
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.
Access Total T3, A34435H, Catalog No. 33830
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Medtest Holdings
Class I - Dangerous
Incorrect control range in product labeling
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Class I - Dangerous
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Olympus Corporation of the Americas
Class I - Dangerous
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Cotton tip of the device may disengage due to insufficient adhesive
Class I - Dangerous
The incorrect Loctite adhesive was used to assemble the impactor heads.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.