Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott determined that 17% of the two reagent lots listed in this fsn may exhibit lower relative light units (rlus) than expected, which in turn may result in controls out of range or patient results higher than expected.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The cell-dyn ruby allows the display of parameter results in usa, international system of
units (si), modified international system of units (si mod), unit set 1 or unit set 2 per user
configuration. abbott has identified the following issue related to unit set selection for celldyn
ruby analyzers using system software versions 2.2ml and lower:
standard deviation (sd) values for select parameters (refer to table a) in the qc views
only (qc-qcid data view and qc-levey jennings) will be incorrectly displayed when unit
sets other than the usa unit are selected on the cell-dyn ruby. these units are
incorrectly converted from usa units to other unit sets for display purposes.
means, percent cv, and limit (upper and lower) information in qc views are correct. in
addition, instrument flagging, alerts, and results are correct for all unit sets.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Usage of either axsym free t4 standard calibrator or control n their own may have resulted in an observation of controls out of range. using them both together may have resulted in a valid calibration and depressed patient results may have been observed.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott has observed cases in which the outflow graft bend relief (ogbr) on the heartmate 3 (hm3) left ventricular assist system (lvas) was not fully and evenly secured to the outflow graft.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott is advising you that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
1. a small number of precision xceedpro blood glucose test strips lots produce control solution results out of range and higher than expected percentage coefficient of variation and standard deviation with controls. this issue does not affect patient blood glucose or β-ketone results, as confirmed through the manufacturer internal testing of retained strips and performance monitoring program.
2. precision xceedpro monitors with serial numbers beginning with “kc” do not fully support a subset of the following barcode types: interleaved 2 of 5 (i 2 of 5), code 128 and code 39. as stated in label copy, if you cannot scan a barcode using the barcode scanner, the data entry keypad on your precision xceedpro monitor allows you to manually enter identification numbers and letters.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
At extremely high blood glucose levels of 1024 mg/dl and above, the freestyle insulinx meter will display and store in memory an incorrect test result that is 1024 mg/dl below the measured result.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott has determined that a barcode issue exists with axsym ausab reagent kit lot # 04278lf00. for axsyms operating on assay disk version 4.0 (list number 9a15-04), the instrument will report error code 0198 "test request denied, assay version number and reagent pack version number must match" when attempting to utilize the impacted reagent lot.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
A nylon washer, used on the shear valve assembly, may have an undersized outer diameter that can potentially get caught within an adjacent drive plate opening. this issue may not appear on all instruments. when the nylon washer gets caught, the analyzer will generate “shear valve position” faults or “rbc diluent syringe overpressure” sims.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Abbott diagnostics has received information from toshiba, the supplier of the ict pre-amp board, indicating the board’s photo couplers may degrade over time. affected architect csystems will generate repeated calibration failures for the ict analytes (sodium, potassium, and chloride).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott diagnostics is recalling clinical chemistry alkaline phosphatase reagents due to particulate matter identified as a cladosporium fungal species in some reagent cartridges.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The purpose of this letter is to communicate a field correction regarding the product labeling for safety precautions associated with the architect testosterone assay.
the current labels and package inserts for the architect testosterone reagent, ln 7k73- 20 and 7k73-25, architect testosterone calibrators, ln 7k73-01 and architect testosterone controls, ln 7k73-10 do not contain the warnings and precautions applicable to material containing methylisothiazolones which are classified as skin sensitizers.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Abbott has confirmed that the c-peptide lots listed above have the potential to generate falsely
elevated results with certain patient samples and with non-abbott controls.Only certain patient samples will show a shift in results. the effect on results varies from sample
to sample.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott has confirmed an increase in calibration failures when using lot 56940ui00. replacement material is available.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The architect havab-igg assay shows a shift in the serum and plasma results to higher s/co values over time, potentially leading to reduced specificity and increasedfalse reactive results.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Explanation the purpose of this communication is to provide instructions on actions your laboratory must take regarding a single lot of architect stat troponin-i reagent. this issue is specific for lot 74264un11. abbott has confirmed that architect stat troponin-i, lot 74264un11 is demonstrating a shift in expected results in some cases. this effect can vary from kit to kit. all levels of abbott controls will detect the shift. if controls are out of range, performing a recalibration will restore the controls in range and accurate results would be generated. as described in the architect stat troponin-i package insert, it is recommended that each control level be tested once every 24 hours each day of use. an investigation is in process. initial indications suggest that the issue is caused by depressed relative light unit (rlu) values.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Potential to
generate falsely elevated or falsely depressed results when the assay is used with the attached
architect reaction vessel (rv) (ln 7c15-01) lots.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Abbott has become aware of an error in the maximum on-board stability time displayed on the architect for the 100-test kit size of architect 25-oh vitamin d list 3l52-25 lot 01110l000.
the barcode error eliminates the ability of the instrument to prevent the use of reagents that are on board the instrument greater than 7 days (168 hours).