Siemens Healthcare Forced to Recall Diagnostics Panels

Siemens Healthcare Diagnostics is recalling all of its Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 diagnostics kits due to problem that can cause the kits to deliver incorrect results.

The tests are designed to identify three gram negative bacteri — Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa — and measure how they respond to antibiotics such as aztreonam, cefotaxime, ceftazidime and ceftriaxone, aiding physicians in choosing the best treatment for the patient, according to a recall notice posted Monday to the FDA’s website. However, some have been found to report bacteria as sensitive to one of these drugs when they are actually resistant, the notice says.

Using the recalled devices may result in ineffective treatment and, in rare instances, contribute to patient death, the notice continues. The FDA has designated the recall Class I, the most serious type.

The Sacramento, Calif., company sent an “Urgent Medical Device Recall” letter to customers on Oct. 17 and again on Nov. 17, asking them to stop using the products and discard any inventory. The company doesn’t plan to replace the recalled products, as they are no longer being produced.

Siemens is still investigating the cause of the false tests. The recall includes all units manufactured between Nov. 1, 2013 and Aug. 11, 2014, and distributed from December 2013 to September 2014.
View the recall notice at http://www.fdanews.com/12-03-14-SiemensRecall.pdf — Kellen Owings

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