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FDA bans Gambro imports

Sweden-based medical technology company Gambro has had imports to the United States of some of its products halted by the American Federal Drug Administration (FDA).

Published: 9 January 2006 12:56 CET

The ban applies to Gambro’s Prisma, Prismaflext and Phoenix monitors for kidney dialysis. The FDA stopped imports and sent a warning letter to the company after an inspection of Gambro’s monitor factory in Medolla, Italy. The agency criticised the instructions for using the machines, among other things.

Gambro has headquarters in Stockholm and employs 900 people in Lund.

Spokeswoman Paula Treutiger said that there “are no faults whatsoever with the machines.”

“The FDA has concerns about the security of the system, and we are now making sure that it is used correctly,” she said.

Imports to America will in the first instance be banned for fifteen days, during which time the company will put together a response to the FDA’s concerns.

Gambro’s share price fell on the Stockholm stock exchange after the news of the ban became public.

TT/The Local

ENVIRONMENT

Sweden’s SSAB to build €4.5bn green steel plant in Luleå 

The Swedish steel giant SSAB has announced plans to build a new steel plant in Luleå for 52 billion kronor (€4.5 billion), with the new plant expected to produce 2.5 million tons of steel a year from 2028.

Published: 2 April 2024 13:44 CEST
Sweden's SSAB to build €4.5bn green steel plant in Luleå 

“The transformation of Luleå is a major step on our journey to fossil-free steel production,” the company’s chief executive, Martin Lindqvist, said in a press release. “We will remove seven percent of Sweden’s carbon dioxide emissions, strengthen our competitiveness and secure jobs with the most cost-effective and sustainable sheet metal production in Europe.”

The new mini-mill, which is expected to start production at the end of 2028 and to hit full capacity in 2029, will include two electric arc furnaces, advanced secondary metallurgy, a direct strip rolling mill to produce SSABs specialty products, and a cold rolling complex to develop premium products for the transport industry.

It will be fed partly from hydrogen reduced iron ore produced at the HYBRIT joint venture in Gälliväre and partly with scrap steel. The company hopes to receive its environemntal permits by the end of 2024.

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The announcement comes just one week after SSAB revealed that it was seeking $500m in funding from the US government to develop a second HYBRIT manufacturing facility, using green hydrogen instead of fossil fuels to produce direct reduced iron and steel.

The company said it also hoped to expand capacity at SSAB’s steel mill in Montpelier, Iowa. 

The two new investment announcements strengthen the company’s claim to be the global pioneer in fossil-free steel.

It produced the world’s first sponge iron made with hydrogen instead of coke at its Hybrit pilot plant in Luleå in 2021. Gälliväre was chosen that same year as the site for the world’s first industrial scale plant using the technology. 

In 2023, SSAB announced it would transform its steel mill in Oxelösund to fossil-free production.

The company’s Raahe mill in Finland, which currently has new most advanced equipment, will be the last of the company’s big plants to shift away from blast furnaces. 

The steel industry currently produces 7 percent of the world’s carbon dioxide emissions, and shifting to hydrogen reduced steel and closing blast furnaces will reduce Sweden’s carbon emissions by 10 per cent and Finland’s by 7 per cent.

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