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Siemens’ high-risk recall affects more than 78,000 antimicrobial tests

September 5, 2013 By Mass Device

FDA regulators put their highest risk Class I label on Siemens recall of its MicroScan Synergies plus and MicroScan rapID/S plus antimicrobial tests.

FDA Class I recall of more than 78,000 Siemens’ antimicrobial tests

FDA regulators put their highest-risk Class I label on Siemens’ (NYSE:SI) recall of more than 78,000 of its MicroScan Synergies plus and MicroScan rapID/S plus antimicrobial tests, warning that false test results could hinder patient care.

The 5 lots of Siemens’ tests, which were distributed between July 11, 2001 and Aug. 2, 2013, were recalled for reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System, the FDA said.