Siemens Healthcare Diagnostics, Inc., of West Sacremento, California, recalled two of their panels used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria in urine. MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels report 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.
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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication