Siemens Dx test panel recall draws FDA's 'most serious' label

Siemens is recalling thousands of test panels used to help screen patients for resistance to antimicrobial drugs because a defect is leading to bogus results. The FDA has assigned its most serious "Class I" status to the effort because of the risk of injury or death.

Specifically, regulators are targeting Siemens Healthcare Diagnostics' MicroScan Synergies Plus and MicroScan rapID/S plus Negative panels, both made for use with the company's MicroScan WalkAway system. The reason? According to the FDA, both are generating "false susceptible" and "false intermediate" results as to whether patients will respond to imipenem and meropenem--antibiotics doctors use to treat a wide range of serious infections.

According to the Centers for Disease Control and Prevention (CDC), patients found to have infections resistant to either drug face far more limited treatment options. And the FDA upgraded the recall effort to something more serious because that malfunction could lead to patients being treated with a poorly matched antibiotic or the right therapy being delayed.

Siemens has been proactive. As the FDA recall notice explains, the company sent an Urgent Field Safety Notice on Aug. 21 to affected customers identifying the affected products, the problem and ways to address it. The recall affects 78,020 panels distributed in the U.S. between July 11, 2011, and Aug. 2, 2013. Siemens told customers to suppress reporting of sensitive and intermediate results for both drugs and also urged review of previous test results, patient follow-up and/or repeat testing. Plans are also under way to add an "important product information notice" to future test panels.

- here's the FDA notice
- and the CDC background

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