Recall of Lab Tests Producing Inaccurate Results; Ineffective Patient Treatment

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:

  • Stop using the recalled devices.
  • Discard any remaining products in inventory.
  • Complete and return the Field Correction Effectiveness Check that is attached to the Urgent Medical Device Recall letter.
  • Forward the Urgent Medical Device Recall letters to others who may have received the recalled devices.

The firm’s second letter included the following information:

  • The firm is unsure when the increase in false test results for the Rapid Gram Negative Combo Panels may have occurred or what caused the false results.
  • Combo Panel lots, distributed prior to those listed in the October 17, 2014 Urgent Medical Device Recall letter, may have produced incorrect readings.
  • The firm will not replace Rapid Gram Negative Combo Panels because they are no longer being marketed.
  • The identification of the gram negative bacterial species is not affected by the recall.
  • The recall does not affect antimicrobial susceptible testing or identification on Dried Overnight Gram Negative panels.
  • Customers should discuss this recall with their medical directors and the need to review previous test results, conduct patient follow-up, and/or repeat testing by another panel type if patient samples are still available.
  • Customers do not have to complete a new Field Correction Effectiveness Check if previously submitted

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.

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