The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
Class I - Dangerous
ABL800 analyzer, model numbers 393-800 and 393-801.
Radiometer America
Class I - Dangerous
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Howmedica Osteonics
Class I - Dangerous
Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19
Alinity i Progesterone Reagent Kit, List Number 08P3620
Abbott Ireland Diagnostics Division
Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Class I - Dangerous
Potential for leakage due to defect in the thermoset check valve component.
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Abbott Ireland Diagnostics Division
Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Class I - Dangerous
Class I - Dangerous
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
In2bones USA
Class I - Dangerous
The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.
Class I - Dangerous
Alinity i Estradiol Reagent Kit, List Number 07P5020
Abbott Ireland Diagnostics Division
Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Class I - Dangerous
Alinity i Free T4 Reagent Kit, List Number 07P7030
Abbott Ireland Diagnostics Division
Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Class I - Dangerous
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
Class I - Dangerous
Potential for leakage due to defect in the thermoset check valve component.
Class I - Dangerous
Potential for leakage due to defect in the thermoset check valve component.