Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results

Including Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1

[Posted 12/2/2014]

AUDIENCE: Risk Manager

ISSUE: 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.

See the FDA Recall Notice for affected catalog and lot numbers.

BACKGROUND: These devices can identify certain gram negative bacteria and 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.

RECOMMENDATION: On October 17, 2014 and again on November 7, 2014 the firm sent Urgent Medical Device Recall letters to their customers stating the problem and the steps to be taken. 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, and forward the Urgent Medical Device Recall letters to others who may have received the recalled devices.

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

[12/1/2014 - Recall Notice - FDA]