Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic device (IVD)) 의 리콜

Recall

RC-2013-RN-01019-1

Class I

2013-09-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01019-1

An internal investigation indicates that specific lots of check valves used in several locations within the lh 750 and lh 780 analysers may fail. this failure may result in air or liquid leak at the connection to the vacuum overflow tank waste line or at the backwash tank drain line. there is a remote risk of reporting false high or false negative results for all parameters on control and patient samples if the backwash tank fails to refill after manual aspiration. there is also a risk for a leak of biohazardous waste if the check valve fails at the vacuum overflow tank waste line. this risk is limited to samples analysed using the manual aspiration mode.

Beckman Coulter is recommending users review manual mode sample results if the "Backwash Tank Not Full" error occurs for all samples obtained since the last acceptable QC run. Beckman Coulter is advising users to avoid physical contact with a possible leak and follow personal protective equipment (PPE) guidelines as recommended in the Instructions for Use (IFU). Beckman Coulter will be contacting all sites to arrange an on-site visit to inspect valves and replace any affected valves.