Siemens Diagnostic Panels Recalled—Potentially Deadly Threat

Siemens Healthcare Diagnostics (West Sacramento, CA) faces a Class I recall for its MicroScan Synergies plus and rapID/S plus negative panels. According to the company, both these panels may report false intermediate and false susceptible results for meropenem and imipenem antimicrobial susceptibility when used in conjunction with the MicroScan WalkAway System.

In total, the Class I recall covers over 78,000 panels manufactured between July of 2011 and August of 2013. Impacted panels include the Synergies plus Negative Urine Combo 1- 10444745 / B1025-106, the Synergies plus Negative Combo 2 - 10444747 / B1025-108, the Synergies plus Negative Breakpoint Combo 7 - 10444748 / B1025-109, the Synergies plus Negative Urine Combo 2 - 10444749 / B1025-112 and the Synergies plus Negative Urine Combo 5 - 10483101 / B1025-115.

FDA regulators note that the defect in the panels could cause a delay in the initiation of appropriate therapy. In some cases, the defect could potentially lead to patient treatment with the incorrect antibiotic.

In response to the recall, Siemens issued an Urgent Field Safety Notice on August 21st to all impacted customers. In the letter, customers were told to cease the reporting of all intermediate and sensitive results for meropenem and imipenem. In addition, the company recommended that customers review previous test results that utilized the panels.