ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra 의 리콜

Recall

RC-2018-RN-00033-1

Class II

2018-01-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00033-1

Siemens healthcare diagnostics has identified the following issues:- the advia centaur cp, xp and xpt systems will not expire the multi-diluent 15 pack at the end of the required 7-day on board stability (obs), if any of the affected bnp or tsh3ul lots are present on the system(s) when performing on-board dilutions; and.- on the advia centaur xpt only, the system becomes inoperable under the following scenario: 1) scanning the master curve card of advia centaur bnp kit lots ending in 193 or higher or advia centaur tsh3-ultra kit lots ending in 301 or higher, and 2) processing a bnp or tsh3ul onboard dilution of a sample. in this case, the system may display an “unknown state” message and requires customer action. when this error occurs, any tests that are in-process would have to be repeated.

Siemens is advising customers who use ALL ADVIA Centaur Systems: - Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected product kit lots are present on the system - Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. For customers using ADVIA Centaur XPT Systems, if users intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, users must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. For customers using ADVIA Centaur CP Systems, if any of the affected BNP kit lots or TSH3UL kit lots have been in use on the system, users must manually track the time that the Multi-Diluent 15 has been in use on board the system.