Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-20 Automated Haematology Analysers) 의 리콜

Recall

RC-2017-RN-01275-1

Class II

2017-10-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01275-1

Sysmex has advised that specific lots of the fluorocell plt reagent may be susceptible to environmental factors causing a decrease in their fluorescence over time. in such instances, the affected lots could lead to a false low plt-f value, which will be inconsistent with the plt-i value.

Roche is advising customers to discard any affected lots of Fluorocell PLT in use or stock. If available, users should use cartridges of an unaffected lot of Fluorocell PLT. Users should ensure that they perform reagent replenishment for Fluorocell PLT to flush out the old lot and completely replenish with unaffected reagent. If no other lot of Fluorocell PLT is available, please check PLT-F results for plausibility. If the PLT-F results are not plausible, please refer to the PLT-I results from the impedance channel. Users should follow internal SOP's regarding retrospective judgement of affected samples. Contact Roche Diagnostics Australia to discuss the need for replacement product.