Recalled Covid-19 tests were supplied in Singapore for lab use
Abbott Alinity Covid-19 test kits that were recalled as potentially false positive results were supplied in Singapore for use in clinical laboratories, said the Health Sciences Authority (HSA) yesterday.
The clinical laboratories were informed last month of the potential false positive results and were advised that any positive result from this test would require confirmatory testing.
HSA told The Straits Times that it is working with Abbott to roll out "appropriate corrective actions" to address this issue, without elaborating.
This comes after the United States Food and Drug Administration (FDA) said last Thursday that two Covid-19 test kits by Abbott Molecular, a subsidiary of Abbott Laboratories, were being recalled as they can potentially issue false positive results.
The FDA said the recall of the Alinity m Sars-CoV-2 AMP and the Alinity m Resp-4-Plex AMP laboratory test kits by Abbott Molecular was a Class 1 recall - the most serious type.
HSA had granted the Abbott Alinity m Sars-CoV-2 AMP kit provisional authorisation on Sept 14 last year. ST has asked the agency to clarify if the Alinity m Resp-4-Plex AMP was in use here.
The FDA had recommended last month that healthcare providers and clinical laboratories consider retesting positive patient samples with another authorised Covid-19 test.
It said an overflow of one patient sample into another while mixing chemicals with the samples could be related to the false positive results, but that no deaths or adverse health consequences have been reported from the use of the tests. - THE STRAITS TIMES
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