Siemens Healthcare Recalls Bacteria Test Kits that May Produce Incorrect Results


Siemens Healthcare Diagnostics Inc., in consultation with the Food and Drug Administration (FDA) has recalled its Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 test kits. The kits may produce incorrect results for bacteria sensitivity to certain antibiotics.

According to the FDA announcement, the recalled kits may produce incorrect results for antibiotics including aztreonam, cefotaxime, ceftazidime and ceftriaxone.  The test could indicate certain bacteria are sensitive to these antibiotics when the bacteria are actually resistant. The recalled kits were manufactured between November 2013 and August 2014 and distributed from December 2013 to September 2014. 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.

The test kits are used by medical labs to identify certain gram-negative bacteria and measure how these bacteria (Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa) respond to certain antibiotics. Test results help health care providers select the correct antibiotic treatment for a patient, according to the FDA.

Customers should immediately stop using the recalled kits, discard any kits in their inventory, and complete and return the Field Correction Effectiveness Check attached to the recall letter.

Health care professionals and patients are encouraged to report adverse events or side effects related to the product through the MedWatch Safety Information and Adverse Event Reporting Program:



This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.