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Recall of Lab Tests Producing Inaccurate Results; Ineffective Patient Treatment


Siemens Healthcare Diagnostics recalled two laboratory tests used to identify certain gram negative bacteria (Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa) and measure how these bacteria respond to antibiotics such as Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. The tests were recalled because they may produce inaccurate results.

 

Rapid Neg BP Combo Panel Type 3 (B1017-117) and Rapid Neg Urine Combo Panel Type 1 (B1017-167) are laboratory tests that give a definitive identification of certain gram negative bacteria in as little as two and a half hours along with a hospital antibiogram that provides rapid empiric therapy guidance. These panels measure how these bacteria (Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa) respond to antibiotics such as Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone in the laboratory. The results can help health care providers select the correct antibiotic treatment for a patient.

 

A recall was instituted because incorrect test results may occur for the following antibiotics: Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. The test may report certain bacteria as sensitive to one of these antibiotics when the bacteria are actually resistant. Using these recalled devices may cause ineffective patient treatment, and in rare instances may contribute to death.

 

These diagnostic panels were manufactured from November 1, 2013, through August 11, 2014. They were distributed from December 2013 through September 2014. The Rapid Gram Negative Combo Panels are no longer being marketed.

 

See the Recall

 

See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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