This article is more than 5 years old. Information may no longer be current.
FDA, manufacturer recall rapid gram-negative combination panels
Click Here to Manage Email Alerts
The FDA issued a class-1 recall for rapid gram-negative combination panels manufactured by Siemens Healthcare Diagnostics Inc.
The manufacturer sent urgent medical device recall letters to customers on Oct. 17 and Nov. 7 for their rapid gram-negative BP combination panel type 3 and rapid gram-negative urine combination panel type 1, manufactured between November 2013 and August 2014 and distributed between December 2013 and September 2014.
Incorrect results may occur for certain antibiotics, including aztreonam, cefotaxime, ceftazidime and ceftriaxone, indicating a certain bacteria is sensitive to these antibiotics when the bacteria is actually resistant, according to an FDA press release.
“Using these recalled devices may cause ineffective patient treatment and, in rare instances, may contribute to death,” according to the release.
Siemens Healthcare Diagnostics Inc. is unsure of what caused false test results.
Customers should stop using recalled devices, discard any remaining products in inventory and complete and return the Field Correction Effectiveness Check attached to the recall letter.
Visit http://www.fda.gov for more information.