Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I Recall - False Susceptible And False Intermediate Results
AUDIENCE: Health Professional, Risk Manager
ISSUE: MicroScan Synergies plus and MicroScan RapID/S plus Negative 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.
BACKGROUND: This recall covers 78,020 panels distributed in the US between 07/11/2011 and 08/02/2013. See the Recall Notice below for a listing of affected part numbers.
RECOMMENDATION: 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. In addition, an Important Product Information notice will be added to products manufactured in future kits.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/12/2013 - Recall Notice - FDA]