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FDA Class I Recall for Siemens Healthcare Bacteria Test Kits

Dec 5, 2014

Siemens Healthcare Diagnostics Inc. has sent urgent medical device recall letters to customers on Oct. 17 and Nov. 7 for their 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.

The recalled kits were manufactured between November 2013 and August 2014 and distributed between December 2013 and September 2014, according to the FDA recall announcement. Incorrect results may occur for antibiotics including aztreonam, cefotaxime, ceftazidime and ceftriaxone, indicating certain bacteria are sensitive to these antibiotics when they are actually resistant, according to the FDA news release. “Using these recalled devices may cause ineffective patient treatment and, in rare instances, may contribute to death.” This is a Class I recall, the FDA’s most serious category, reserved for products whose use may result in serious adverse health consequences, including death.

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

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

The FDA encourages health care professionals and patients to report adverse events or side effects through the MedWatch Safety Information and Adverse Event Reporting Program:

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