Beckman Coulter Recalls Tests, Citing Unapproved Changes

Beckman Coulter is recalling a portion of its cardiac troponin assays after making unapproved changes to the diagnostics. AccuTn1 troponin tests used with the company’s Unicel DxI immunoassay system will be removed from U.S. laboratories by May 31, Beckman says in an SEC filing. The FDA informed the company late last month that certain modifications in the troponin test kits used on DxI and Access systems had not been cleared, Beckman says. The company plans to submit new 510(k)s for the AccuTn1 tests used with both systems.
Devices & Diagnostics Letter