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.
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).
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 communication is to provide instructions on actions your laboratory must take regarding architect ca 19-9xr reagent lots listed above.
abbott has confirmed that these six architect ca 19-9xr reagent lots are demonstrating a shift up in patient results.
abbott controls however do not detect the upward shift and will test within range.
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 c4000 cuvette segment may detach from the bottom of the segment. when a cuvette segment is detached, cuvettes may be seated lower than the designed height.
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
Architect toxo igg reagent are showing reduced specificity which may cause a shift to higher iu/ml values leading to increased grayzone and/or 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
Abbott diagnostics is recalling clinical chemistry phenobarbital reagent due to imprecision issues which increase with the age of the reagent.
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: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Alcon confirmed complaints for the 23g non‐valved trocar cannula and infusion cannula related to a loose fit between the non‐valved trocar cannula and infusion cannula. this loose fit may cause the infusion cannula to dislodge from the trocar cannula during the surgical procedure, which may eliminate
the necessary infusion to the eye required to maintain adequate pressure while operating.
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
During in‐house alinity s system assay testing, abbott identified the possibility of unexpected
low rlu (relative light units) values on sample results for all alinity s assays.
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 received the attached letter from sentinel, the manufacturer of the multigent
creatinine (enzymatic) reagent. sentinel have confirmed a performance issue with the three
lots listed above which may result in quality control values shifting out of acceptable ranges
or erratic patient 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
Abbott has confirmed that the architect cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the package insert claim of <15% total cv. calibrators and controls also have the potential to be impacted by the assay imprecision.
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 some kits of axsym valproic acid reagent lot 18439m503 have the potential to generate invalid calibration, control or sample runs due to net intensity too low,
resulting in axsym instrument error code 1072.
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 possibility that two specific production orders of sensar iols contain iols labeled with the incorrect diopter power.
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: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Some packages labeled lpccc1, hexed castable cylinder may contain lpccc2, non-hexed castable cylinder.
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 medical optics inc. (amo) is providing this advisory notice to all customers
who use the amo star s4 ir excimer laser system to make you aware of a
discrepancy with pupil centroid shift compensation.
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
Amo has identified a minor discrepancy between the user-set depth of corneal tissue incisions and the actual depth of those incisions by way of in vitro testing.
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 vascular has discovered that some devices may exhibit difficulty inflating and/or deflating.
potential risks associated with this event include prolonged procedure times, additional physician intervention including minor surgery and possible thrombus. there have been no long term or irreversible patient effects reported.