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 identified an issue with the alinity i bulk solution dispense pumps (part number a‐35001280‐01) resulting in pump failures. the issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution(s) that eventually results in the pump failure.
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 phosphorus reagent lot numbers listed above have been labeled with incorrect expiration dating.
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 hematology has identified a potential issue with the alinity hq analyzer. reagent bottles are pierced by a needle assembly connected to an air line (tubing) that serves to vent reagents so that reagents will feed into their respective reagent supply lines. it was determined that liquid from a reagent bottle could leak through the check valve of the air line, which is connected to a common air tubing that is shared by other reagent air lines. this can result in cross‐contamination of reagents and will impact the ability to process samples.
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 identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid reagent (ln 9d89-21).
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 a performance shift for the architect havab‐igm, architect havab‐igg and alinity i havab igg reagent lots as listed in table above has the potential to generate falsely elevated control and patient sample 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
A performance shift in the architect intact pth assay has the potential to generate falsely elevated results on patient samples.
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
Hba1c calibrators ln 4p52-02, lot 45063uq12 may contain a value sheet for a different hba1c calibrator lot.
patient results could be falsely elevated up to an 8% difference due to the use of incorrect calibrator 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
Abbott hematology has identified the following issue with the cell-dyn emerald 22 analyzer application software v3.0.0 when the iuo (information use only) reporting option is disabled: for the printout of the levey‐jennings (l‐j) graphs, the wbc subpopulation differential labels do not match the l‐j graphs. the labels are displayed in the following order: lym%, mon%, neu%, eos% and bas%, instead of neu%, lym%, mon%, eos%, and bas%. the graphs themselves are in the order of neu%, lym%, mon%, eos%, and bas% for clarity: lym% label on the left displays with neu% graph; mon% label on the left displays with lym% graph; neu% label on the left displays with mon% graph; eos% and bas% are correct. the on‐screen results as well as on‐screen graphs are correct. all printed qc raw data results are correct. patient impact 1. patient results are not impacted and there is no potential for delay in 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 point of care inc. (apoc) has determined that celite act and kaolin act cartridges may produce falsely low results when very high clotting time samples are tested.
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 the manufacture of the architect b12 reagent kits (list 7k61) listed above, an incorrect ifu (instructions for use) commodity number g3-0354/r04 may have been inserted into the reagent kits.
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 identified the following issues with the alinity ci‐series which may present a potential performance issue in alinity ci‐series software version 2.10. abbott is releasing alinity ci‐series software version 2.50 to correct these issues (see details in appendix a).
1. removing racks during the maintenance state is not detected by the system.
issues with orders may occur when reloading a rack with samples and returning to running state.
2. orders created using more than one of the i‐series, c‐series, or calculated options to select assays will only include the assays selected in the last filtered view, if the order is saved prior to returning to the all option.
3. enabling an assay when the processing module is in the running or processing status causes the assay to be re‐installed.
4. a sample with 270 test orders remained in the scheduled status and would not process.
5. some maintenance and diagnostic procedures can appear to have completed successfully when there was insufficient inventory.
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 inform you of a product recall and reduced expiration dating for select architect stat high sensitive troponin-i reagent lots listed in table 1 below and to provide instructions on what actions your laboratory must take.
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 transport mechanism that moves the robot along the axes generates a magnetic field which may interfere with pacemaker/implanted heart defibrillator functionality at close distances. this affects all aps system serial numbers.
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 identified multiple issues (see attached fsn) with the alinity hq and alinity hs software
version 2.0.1, alinity h‐series operations manual (80000023‐105 ‐ 2017‐10‐18) and select hardware. the impacted product (hq and/or hs) are designated for each issue.
........................................
ncmdr update reason :
when the ias3 channel of the rbc optical tracking goes out of specification, this results in an increase in rbc fragment flags. rbc fragment flags indicate the presence of rbc fragments or schistocytes. rbc fragments can make rbc results suspect or invalid based on the degree of fragmentation.
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
Biokit has identified a stability issue with the quantia ferritin / myoglobin / ige control not meeting the 15 day reconstituted stability product claim. this issue may have caused that controls be out of 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, MHRA, FDA
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Freestyle flash and freestyle blood glucose meters may produce erroneously low blood glucose results when using freestyle lite and freestyle blood glucose test strips.
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 anti-hbc ii assay shows lower calibrator, control and sample rlu values, potentially leading to reduced specificity and increased false 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 has identified that falsely elevated results may be obtained when using the architect dhea‐s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation.
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 drug fulvestrant (faslodex®) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol 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
The interference for n‐acetylcysteine (nac) has increased (resulting in a larger negative bias in acetaminophen concentration), relative to the level reported in the reagent package insert.
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 the attached letter from sekisui medical co., ltd, the manufacturer
of the cp3000 system. sekisui has identified an issue with the current software v1.11 and below on
the cp3000 system that could potentially impact patient results and usability. in addition, the letter
from sekisui includes precautions when using the bottle changeover function with a new lot of
reagent if the instructions in the user manual are not followed.
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 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.
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: BfArM
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Abbott has identified occurrences where the cell-dyn emerald analyzer generates quality control (qc) out of range low for parameters rbc and plt.
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
Product from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
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 company has confirmed an average shift in results of approximately -35% for commercial controls and -22% for college of american pathologists (cap) samples when using tobramycin calibrator.