Beckman Coulter will remove the AccuTnI troponin test kits from use with the company's UniCel DxI immunoassay system on May 31, the company said in an SEC filing issued today.
In the notice, which it sent to its US-based customers, Beckman said that "[a]s previously disclosed, FDA has indicated to us that it believes certain modifications to our troponin test kits, as used on our DxI systems as well as used on our Access systems, were made without obtaining appropriate product clearances from the agency.
"We are in discussions with FDA regarding the 510(k) clearance process for our troponin test kits for both the DxI and Access immunoassay systems," Beckman added. "However, we can not provide any assurances on when we will be able to return troponin to the DxI."
Beckman also said it has also "previously disclosed that, based upon our discussions with FDA, we believe it is likely we will be able to continue to provide troponin test kits with appropriate additional notices and precautions to US customers who currently use Access systems for troponin testing.
"However, we can provide no assurances that FDA will continue to permit us to do so," the company add. "Moreover, for US labs that are not currently using Access systems to perform troponin testing, it is unlikely that we will be able to provide troponin test kits for use on Access analyzers until we obtain 510(k) clearance.
"We are continuing to work to resolve these matters with FDA but can provide no assurances regarding when 510(k) clearance will be obtained," Beckman said.
The letter comes two months after Beckman sent a notice to its US customers "describing the positive bias observed when running our troponin assay, AccuTnI, on UniCel DxI Immunoassay Systems as compared to Access Immunoassay Systems. The positive bias could lead to elevated AccuTnI results when run on DxI Immunoassay Systems."
That letter "recommended, in part, that clinical laboratories that do not have access to a readily available and validated alternative methodology for troponin I measurement should investigate options for obtaining and validating an alternative troponin technology for your institution.
"Because of this serious performance issue, we will be removing the Access AccuTnI assay from use with the DxI Immunoassay Systems as of May 31," Beckman had said. "To ensure that AccuTnI has been removed from DxI Immunoassay System menus, a new assay protocol file is required for all DxI Immunoassay Systems.
"Effective immediately, we encourage you to transition troponin testing from your DxI Immunoassay System(s) to an alternate method. We will install the new APF on DxI Immunoassay System(s) by May 31, after which you will no longer be able to run AccuTnI on your DxI Immunoassay System," the company added. "You will have to complete your transition to an alternate method by May 31."
Beckman concluded: "We are committed to bringing AccuTnI back to market for use on UniCel DxI Immunoassay Systems and we will continue to work closely with the FDA to address these issues as soon as possible."