Recall story reaches climax
China returns US pacemakers that fail quality standards.
By Agencies |
BEIJING: China has returned 272 heart pacemakers imported from the US in April after quality tests found problems that could cause ‘major’ health hazards, the Chinese quality regulator said.
The pacemakers, made by St Paul, Minnesota-based St Jude Medical, had pulse-strength properties that were different from those stated, the General Administration of Quality Supervision, Inspection and Quarantine said in a statement late on Monday on its website. The test-result differences exceeded China’s 2% limit, the regulator said.
The use of unqualified pacemakers will likely lead to misdiagnosis and cause ‘major hazards’ to patients with heart diseases, the regulator said, citing unidentified experts. The products, valued at $236,294 in total, were tested by quality inspectors in Shanghai in April and returned ‘recently’, according to the statement, which didn’t elaborate. St Jude was unavailable for comment when contacted by phone outside of business hours.
Recent reports of unsafe Chinese products ranging from contaminated fish to pesticide-laced vegetables have intensified trade friction between the US and China. While defending the quality of its exports, China also pledged to strengthen quality control of its imports. Those that fail to meet Chinese standards will be ‘destroyed, returned or banned from being imported’, the quality regulator said in Monday’s statement.
“There’s likely to be an element of retaliation there,” said Du Jinsong, a Hong Kong-based analyst with Credit Suisse Group. Tighter quality controls on imported medical devices suggest Chinese companies will “find it easier to take market share from foreign players,” Du said.
A global manhunt launched by Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels. Potentially dangerous copies of the company’s OneTouch Test Strip surfaced in American and Canadian pharmacies last year, according to federal court documents unsealed in June. China in June destroyed apricot products from Vacaville, California-based Mariani Packing after tests found excessive bacteria.
China’s State Food and Drug Administration in 2001 launched an urgent investigation into four types of pacemakers produced by St Jude Medical because of reliability issues, resulting in imports of the pacemakers being banned, the media reported on Monday night. It didn’t say whether the banned pacemakers were the same type as those returned in April.
The pacemakers, made by St Paul, Minnesota-based St Jude Medical, had pulse-strength properties that were different from those stated, the General Administration of Quality Supervision, Inspection and Quarantine said in a statement late on Monday on its website. The test-result differences exceeded China’s 2% limit, the regulator said.
The use of unqualified pacemakers will likely lead to misdiagnosis and cause ‘major hazards’ to patients with heart diseases, the regulator said, citing unidentified experts. The products, valued at $236,294 in total, were tested by quality inspectors in Shanghai in April and returned ‘recently’, according to the statement, which didn’t elaborate. St Jude was unavailable for comment when contacted by phone outside of business hours.
Recent reports of unsafe Chinese products ranging from contaminated fish to pesticide-laced vegetables have intensified trade friction between the US and China. While defending the quality of its exports, China also pledged to strengthen quality control of its imports. Those that fail to meet Chinese standards will be ‘destroyed, returned or banned from being imported’, the quality regulator said in Monday’s statement.
“There’s likely to be an element of retaliation there,” said Du Jinsong, a Hong Kong-based analyst with Credit Suisse Group. Tighter quality controls on imported medical devices suggest Chinese companies will “find it easier to take market share from foreign players,” Du said.
A global manhunt launched by Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels. Potentially dangerous copies of the company’s OneTouch Test Strip surfaced in American and Canadian pharmacies last year, according to federal court documents unsealed in June. China in June destroyed apricot products from Vacaville, California-based Mariani Packing after tests found excessive bacteria.
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China’s State Food and Drug Administration in 2001 launched an urgent investigation into four types of pacemakers produced by St Jude Medical because of reliability issues, resulting in imports of the pacemakers being banned, the media reported on Monday night. It didn’t say whether the banned pacemakers were the same type as those returned in April.
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