The Food and Drug Administration has issued a Class I Recall—False Susceptible and False Intermediate Results for the Siemens MicroScan Synergies plus and MicroScan RapID/S plus Negative Panels. These panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System. This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. The recall covers 78,020 panels distributed in the United States between July 11, 2011, and August 2, 2013. The affected Material Numbers / Part Numbers are as follows: Synergies plus Negative Urine Combo 1- 10444745 / B1025-106; Synergies plus Negative Combo 2 – 10444747 / B1025-108; Synergies plus Negative Breakpoint Combo 7 – 10444748 / B1025-109; Synergies plus Negative Urine Combo 2 – 10444749 / B1025-112; Synergies plus Negative Urine Combo 5 – 10483101 / B1025-115.
Siemens sent an Urgent Field Safety Notice dated August 21, 2013, to all affected customers. The letter identified the defective products, problem, and actions to be taken. The letter instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. Read the text of the FDA alert.
