Banned Cancer and Heart Disease Testing Kits Still Sold in Britain

Strategic Insights -

British hospitals are using hundreds of testing kits for cancer and heart disease, which have been banned in the US due to manufacturing problems. Abbott Laboratories, the largest maker of diagnostic tests, was fined $100 million by the US Food and Drug Administration (FDA) after failing to comply with quality assurance rules for six years. The FDA allowed the company to continue selling the products for 30 days to allow users to find alternative kits.

Key Takeaways:

  • The FDA criticized Abbott Laboratories for failing to comply with quality assurance rules for six years, resulting in a $100 million fine.
  • The FDA ban applies only to the United States, and the company can still export its goods to Britain and other countries.
  • Abbott Laboratories' test kits are used in hundreds of British hospitals and laboratories to diagnose cancer and heart disease.
  • The FDA did not rule that the products were faulty, unsafe, or had failed to diagnose diseases, but said that the failure to comply with regulations "decreases the level of assurance".
  • The FDA recommends additional quality controls by other companies, but did not suggest a recall of existing products.
  • Abbott Diagnostics UK wishes to cooperate with the Medical Devices Agency and has not withdrawn any product licenses for its UK products.
  • Whitehall sources confirm that Britain's blood supplies are not dependent on the banned testing kits.

Statistics:

  • Abbott Laboratories was fined $100 million by the FDA.
  • The ban on Abbott's testing kits applies only to the United States.
  • The FDA allowed the company to continue selling the products for 30 days to allow users to find alternative kits.
  • Abbott Laboratories exports thousands of kits to Britain every year.
  • The products involved are in-vitro diagnostic kits for laboratory tests of patients' blood, urine, and other bodily fluids.
  • The FDA found no evidence that any of the devices produced by Abbott had failed to perform as intended.

Sources:

  • "Abbott Laboratories may lose UK sales", The Times, 1999 (no date provided in the original text)