Retiro De Equipo (Recall) de Various Microgenics Applications Sheets. An in vitro diagnostic medical device (IVD)

Recall

RC-2017-RN-00871-1

Class II

2017-07-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00871-1

It has been determined that application sheets provided by the manufacturer microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use (ifu) when not used on manufacturer approved analysers, is inadequate. in addition, microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.Thus the information given on the specific application sheets for use with non-microgenics approved analysers may be ineffective. it is possible that assays not validated for use with other instrument platforms could potentially lead to erroneously low or high test results.

Beckman Coulter is requesting Customers: 1. Immediately check if they are using any of the affected Application Sheets on the platforms as listed in the letter supplied; and 2. Discontinue use of the affected Application Sheets. Review their internal assay validations to determine if the current instrument settings using these Assays require additional action within the clinical laboratory setting. If customers have performed a compliant self-validation of a particular Assay on a specific instrument in accordance with applicable laboratory certifications or requirements, they may be able to continue to use that Assay on the corresponding instrument. Consult a qualified healthcare professional as appropriate. If they have performed a compliant self-validation, note that on the supplied Vigilance Response Form.