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 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.
Siemens representatives didn't respond to a request for comment.
These antibiotic agents are used to treat a number of serious microbial infections that are resistant to the antibiotic of choice, and are commonly used to treat hospital-acquired and mixed-bacterial infections, according to the Centers for Disease Control & Prevention.
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