Siemens recalled two laboratory tests used to identify certain 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. Unfortunately, incorrect test results may cause “ineffective patient treatment and, in rare instances, may contribute to death,” the FDA warns. This action is a Class I recall, the most serious category, reserved for products whose use may result in serious adverse health consequences, including death.
Customers who have these recalled devices in their inventory should:
The firm’s second letter included the following information:
Public Contact: Customers who need additional assistance should contact the Siemens Customer Care Center at 1-800-988-2477 (24 hours a day, 7 days a week) or their local Siemens Technical Support Representative.